Endometrial Cancer
Conditions
Keywords
Strength Training, Resistance Training, Obesity, Sedentary
Brief summary
This 2-arm pilot trial will enroll 40 participants to test the feasibility, adherence, and benefits of a home-based strength training intervention for endometrial cancer survivors relative to a wait-listed control group.
Detailed description
Endometrial cancer survivors have an extremely high prevalence of inactivity and obesity. Inactivity and obesity are associated with poorer outcomes among survivors. Other interventions have demonstrated that walking and aerobic exercise are safe and feasible in endometrial cancer patients. However few published studies have examined strength training in endometrial cancer survivors, and these have done so only in combination with aerobic intervention (and often also dietary change) in the context of a larger multi-component intervention. There is a critical need for data about the feasibility and benefits of strength training in this population. The investigators propose a 2-arm pilot trial of a home-based strength training intervention (vs. waitlist control) among 40 endometrial cancer survivors. The intervention will consist of (a) an initial in-person instructional session; (b) instructional materials and resistance training equipment (e.g., resistance bands) and (c) support and feedback provided via video coaching sessions. The purpose of a pilot trial is not to conduct hypothesis testing, but rather to field-test the logistical components of the study to incorporate into a larger, future study design. The proposed trial will determine the feasibility of an at-home resistance training protocol and measurements of exercise logging, functional fitness testing, DXA, dried blood spots and questionnaire measures. Participants will be assigned either to the resistance training program (i.e., initial in-person instructional session, telephone coaching, and self-monitoring) or to a comparison arm (wait-list control). * Aim 1: To determine the feasibility of recruiting and retaining endometrial cancer survivors to a home- based resistance training 2 sessions per week of 20-40 minutes of exercise. * Aim 2: To determine participant satisfaction with each component of the intervention and identify opportunities for refinement of the intervention prior to testing in a larger study. * Aim 3: To establish that functional and objective assessments are feasible and well-tolerated in enrolled participants, as assessed using the functional fitness test (FFT) battery, dual-energy x-ray absorptiometry (DXA), finger-pricks for dried blood spots and patient-reported outcomes.
Interventions
OTHERBaseline Measures
Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.
BEHAVIORALStrength-Training
2 sessions per week (20-40 min), home-based resistance training
OTHERMid-point Measures
Accelerometer (steps)
OTHERPost-Study Measures
Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.
Sponsors
National Cancer Institute (NCI)
American Cancer Society, Inc.
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Willing to provide written informed consent * Willing to comply with all study procedures and be available for the duration of the study * Fluent in spoken and written English * Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years * Completion of current treatment for endometrial cancer, period of time of ≥10 weeks from treatment completion to study enrollment is required
Exclusion criteria
* Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations * Have evidence of recurrent or metastatic disease * Are currently performing resistance training ≥2 days per week * Report of chest pain, shortness of breath, fainting, or angina pectoris * Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block * Plans to move from the area * Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization * Women who are pregnant or breast-feeding * Not suitable for study participation due to other reasons at the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Number of Participants Recruited | up to 2 years | The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants. |
| Number of Participants Who Completed 100% of the Prescribed Exercises | up to 20 weeks from beginning of intervention | Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session. |
| Number of Participants With Adverse Events | up to 20 weeks | The primary safety endpoint will be total number of adverse events over the duration of the intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in C-Reactive Protein From Baseline | baseline and 10 weeks | Baseline and post-study blood biomarkers to assess c-reactive protein will be collected and reported in a table as a change from baseline. |
| Change in Lean Muscle Mass From Baseline | baseline and 10 weeks | Baseline and post-study lean muscle mass will be assessed using dual-energy absorptiometry (DXA) using the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline. |
| Change in Fat Mass From Baseline | baseline and 10 weeks | Baseline and post-study fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline. |
| Change in Visceral Fat Mass From Baseline | up to 20 weeks | Baseline and post-study visceral fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline. |
| Change in Total Percent Body Fat From Baseline | baseline and 10 weeks | Baseline and post-study % body fat will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline. |
| Change in Number of Arm Curls Performed From Baseline | baseline and 10 weeks | Arm curls are part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. These tests will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second arm curl assesses the strength of the upper body, where participants hold a 5 pound dumbbell in a seated position, and they will have 30 seconds to curl their arm and extend it as many times as possible within the time frame. |
| Change in Number of Sit to Stand Repetitions Performed From Baseline | baseline and 10 weeks | The 30 second chair stand is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second chair stand assesses the strength of the lower body. Each person will have 30 seconds to stand up and sit down from a chair as many times as possible within the time frame. |
| Change in Sit and Reach Distance From Baseline | baseline and 10 weeks | The chair sit and reach test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The chair sit and reach assesses lower body flexibility where the participant will sit in a chair, extend one leg in front of them and flex at the waist, reaching toward their toes, the measure is the distance between their toes and fingers. |
| Change in Back Scratch Distance From Baseline | baseline and 10 weeks | The back scratch test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The back scratch test assesses the upper body flexibility, where the person is seated and one arm will be flexed behind the head, and the other arm will be extended behind the shoulder. The assessment measures the distance between the finger tips of both hands. |
| Change in 6-minute Walk Distance From Baseline | baseline and 10 weeks | The 6-minute walk test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 6 minute walk test measures the total distance that a person can quickly walk on a flat hard surface within a period of 6 minutes, using a 100ft length of distance. |
| Change in 8 Foot Up and Go Time From Baseline | baseline and 10 weeks | The 8-foot-up and go test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 8-foot-up and go is an assessment of speed agility and balance. The participant begins in a seated position and will be timed for the duration it takes to rise from the chair, walk as quickly as possible around a cone 8 feet away from the chair, and return to a seated position. |
| FACT Scores | baseline, 5 weeks, 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such. |
| Change in Handgrip Weight From Baseline | baseline and 10 weeks | Handgrip is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. \[can you describe this test? I do not see it in the protocol\] |
| FACT-En Scores | baseline, 5 Weeks,10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements. |
| Changes in FACT-En From Baseline | baseline and 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements. |
| FACT Physical Subscale Scores | baseline, 5 weeks, 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements. |
| FACT Social Subscale Scores | baseline, 5 weeks, 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements. |
| FACT Emotional Subscale Scores | baseline, 5 weeks, 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements. |
| FACT Functional Subscale Scores | baseline, 5 weeks, 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements. |
| Changes in FACT Subscales From Baseline | baseline and 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements. |
| Changes in Mental Well-being From Baseline | baseline and Week 10 | Changes in mental well-being from baseline, mid-point, and post-study (including anxiety, depression, and fatigue) will be assessed using standardized NIH-provided Patient-Reported Outcome Measurement Information System (PROMIS) measures. The fatigue assessment asks about self-reported systems of fatigue and tiredness, all the way up to exhaustion overall, and ask about fatigue over the past seven days. The depression assessment asks about depressive symptoms over the past seven days. The anxiety assessment asks about symptoms adjacent-to and including anxiety over the past seven days. For each of these three instruments (which comprise the mental well-being assessments) the data will be reported as change over time, specifically using the T-score (standardized mean) and the standard error. Each is standardized to a mean of 50 and a range of 0-100; a higher scores indicate a higher level of that construct, whether it's higher levels of depression, fatigue or anxiety. |
| Changes in Self-Efficacy From Baseline | Baseline and 10 weeks | Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time. |
| Self-Efficacy Scores | Baseline, 5 weeks, 10 weeks | Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time. |
| Changes in Accelerometer-Measured Physical Activity From Baseline | baseline and Week 10 | Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period. Light intensity is Moderate intensity is Vigorous intensity is |
| Change in Steps Per Day From Baseline | baseline and Week 10 | Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period. |
| Changes in FACT From Baseline | baseline and 10 weeks | Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such. |
| Number of Participants Reporting Very or Extremely Satisfied With Intervention | At final visit - up to 20 weeks | Participants will complete semi-structured qualitative interviews with the study coordinator. Interviews will be recorded, transcribed and coded to identify content themes. These interviews will be used to collect qualitative information and overall satisfaction with the intervention, as well as areas to improve with future interventions and barriers to participation. |
| Change in Hemoglobin A1c From Baseline | baseline and 10 weeks | Baseline and post-study blood biomarkers to assess Hemoglobin A1c will be collected and reported in a table as a change from baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strength-Training Intervention Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with 5 week follow up period. | 20 |
| Waitlist Control Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Strength-Training Intervention | Waitlist Control | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 9.6 | 60.9 years STANDARD_DEVIATION 8 | 60.9 years STANDARD_DEVIATION 8.7 |
| Body Mass Index (BMI) | 42.2 kg/m2 STANDARD_DEVIATION 19.5 | 37.9 kg/m2 STANDARD_DEVIATION 8.6 | 39.9 kg/m2 STANDARD_DEVIATION 15.2 |
| Education College graduate | 6 Participants | 8 Participants | 14 Participants |
| Education High school graduate or less | 1 Participants | 2 Participants | 3 Participants |
| Education Post-graduate degree | 6 Participants | 4 Participants | 10 Participants |
| Education Trade school / some college | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hip Circumference | 130.2 centimeters STANDARD_DEVIATION 18.4 | 129.2 centimeters STANDARD_DEVIATION 19.4 | 129.7 centimeters STANDARD_DEVIATION 18.7 |
| Married or Partnered | 15 Participants | 13 Participants | 28 Participants |
| Percentage Total Body Fat | 51.6 percent body fat STANDARD_DEVIATION 5 | 50.4 percent body fat STANDARD_DEVIATION 6.8 | 51.2 percent body fat STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 19 Participants | 39 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time since diagnosis | 2.8 years STANDARD_DEVIATION 1.2 | 3.0 years STANDARD_DEVIATION 1.3 | 2.9 years STANDARD_DEVIATION 1.2 |
| Time since surgery | 2.7 years STANDARD_DEVIATION 1.4 | 3.0 years STANDARD_DEVIATION 1.3 | 2.8 years STANDARD_DEVIATION 1.3 |
| Treatment Chemotherapy alone | 0 Participants | 3 Participants | 3 Participants |
| Treatment Chemotherapy and Radiation | 4 Participants | 0 Participants | 4 Participants |
| Treatment No treatment beyond surgery | 14 Participants | 16 Participants | 30 Participants |
| Treatment Radiation alone | 2 Participants | 1 Participants | 3 Participants |
| Tumor Stage At Diagnosis Stage 1 | 15 Participants | 18 Participants | 33 Participants |
| Tumor Stage At Diagnosis Stage 2 | 2 Participants | 0 Participants | 2 Participants |
| Tumor Stage At Diagnosis Stage 3 | 3 Participants | 2 Participants | 5 Participants |
| Waist Circumference | 107.9 centimeters STANDARD_DEVIATION 16.9 | 105.5 centimeters STANDARD_DEVIATION 15.2 | 106.8 centimeters STANDARD_DEVIATION 16 |
| Waist-to-Hip Ratio | 0.82 waist-to-hip circumference ratio STANDARD_DEVIATION 0.04 | 0.83 waist-to-hip circumference ratio STANDARD_DEVIATION 0.07 | 0.83 waist-to-hip circumference ratio STANDARD_DEVIATION 0.06 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Feasibility - Number of Participants Recruited
The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants.
Time frame: up to 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength-Training Intervention | Feasibility - Number of Participants Recruited | 20 Participants |
| Waitlist Control | Feasibility - Number of Participants Recruited | 20 Participants |
Primary
Number of Participants Who Completed 100% of the Prescribed Exercises
Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session.
Time frame: up to 20 weeks from beginning of intervention
Population: Waitlist control group was not included in adherence measures as they did not receive exercises until final measures were completed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength-Training Intervention | Number of Participants Who Completed 100% of the Prescribed Exercises | 17 Participants |
| Waitlist Control | Number of Participants Who Completed 100% of the Prescribed Exercises | 0 Participants |
Primary
Number of Participants With Adverse Events
The primary safety endpoint will be total number of adverse events over the duration of the intervention.
Time frame: up to 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength-Training Intervention | Number of Participants With Adverse Events | 0 Participants |
| Waitlist Control | Number of Participants With Adverse Events | 0 Participants |
Secondary
Change in 6-minute Walk Distance From Baseline
The 6-minute walk test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 6 minute walk test measures the total distance that a person can quickly walk on a flat hard surface within a period of 6 minutes, using a 100ft length of distance.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in 6-minute Walk Distance From Baseline | 70.0 feet | Standard Deviation 89.3 |
| Waitlist Control | Change in 6-minute Walk Distance From Baseline | 34.9 feet | Standard Deviation 114 |
Secondary
Change in 8 Foot Up and Go Time From Baseline
The 8-foot-up and go test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 8-foot-up and go is an assessment of speed agility and balance. The participant begins in a seated position and will be timed for the duration it takes to rise from the chair, walk as quickly as possible around a cone 8 feet away from the chair, and return to a seated position.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in 8 Foot Up and Go Time From Baseline | -0.7 seconds | Standard Deviation 0.9 |
| Waitlist Control | Change in 8 Foot Up and Go Time From Baseline | -0.1 seconds | Standard Deviation 1 |
Secondary
Change in Back Scratch Distance From Baseline
The back scratch test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The back scratch test assesses the upper body flexibility, where the person is seated and one arm will be flexed behind the head, and the other arm will be extended behind the shoulder. The assessment measures the distance between the finger tips of both hands.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Back Scratch Distance From Baseline | 1.1 inches | Standard Deviation 1.7 |
| Waitlist Control | Change in Back Scratch Distance From Baseline | 0.1 inches | Standard Deviation 4.1 |
Secondary
Change in C-Reactive Protein From Baseline
Baseline and post-study blood biomarkers to assess c-reactive protein will be collected and reported in a table as a change from baseline.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in C-Reactive Protein From Baseline | 222.1 ng/mL | Standard Deviation 538.3 |
| Waitlist Control | Change in C-Reactive Protein From Baseline | 108.6 ng/mL | Standard Deviation 400.9 |
Secondary
Change in Fat Mass From Baseline
Baseline and post-study fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Time frame: baseline and 10 weeks
Population: Absolution change in fat mass was not reported, instead percent fat change was reported to standardize for total body mass allowing for easier interpretation across individuals.
Secondary
Change in Handgrip Weight From Baseline
Handgrip is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. \[can you describe this test? I do not see it in the protocol\]
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Handgrip Weight From Baseline | 0.7 kilograms | Standard Deviation 2.2 |
| Waitlist Control | Change in Handgrip Weight From Baseline | -0.4 kilograms | Standard Deviation 2.1 |
Secondary
Change in Hemoglobin A1c From Baseline
Baseline and post-study blood biomarkers to assess Hemoglobin A1c will be collected and reported in a table as a change from baseline.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Hemoglobin A1c From Baseline | 4.7 ng/mL | Standard Deviation 8.4 |
| Waitlist Control | Change in Hemoglobin A1c From Baseline | 3.2 ng/mL | Standard Deviation 5.9 |
Secondary
Change in Lean Muscle Mass From Baseline
Baseline and post-study lean muscle mass will be assessed using dual-energy absorptiometry (DXA) using the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Lean Muscle Mass From Baseline | 1.0 pounds muscle | Standard Deviation 2.6 |
| Waitlist Control | Change in Lean Muscle Mass From Baseline | -0.7 pounds muscle | Standard Deviation 3.3 |
Secondary
Change in Number of Arm Curls Performed From Baseline
Arm curls are part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. These tests will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second arm curl assesses the strength of the upper body, where participants hold a 5 pound dumbbell in a seated position, and they will have 30 seconds to curl their arm and extend it as many times as possible within the time frame.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Number of Arm Curls Performed From Baseline | 4.9 repetitions | Standard Deviation 3.7 |
| Waitlist Control | Change in Number of Arm Curls Performed From Baseline | 2.2 repetitions | Standard Deviation 2 |
Secondary
Change in Number of Sit to Stand Repetitions Performed From Baseline
The 30 second chair stand is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The 30 second chair stand assesses the strength of the lower body. Each person will have 30 seconds to stand up and sit down from a chair as many times as possible within the time frame.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Number of Sit to Stand Repetitions Performed From Baseline | 3.3 repetitions | Standard Deviation 3.5 |
| Waitlist Control | Change in Number of Sit to Stand Repetitions Performed From Baseline | 0.3 repetitions | Standard Deviation 2.4 |
Secondary
Change in Sit and Reach Distance From Baseline
The chair sit and reach test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline. The chair sit and reach assesses lower body flexibility where the participant will sit in a chair, extend one leg in front of them and flex at the waist, reaching toward their toes, the measure is the distance between their toes and fingers.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Sit and Reach Distance From Baseline | 0.9 inches | Standard Deviation 2.3 |
| Waitlist Control | Change in Sit and Reach Distance From Baseline | -0.5 inches | Standard Deviation 3.7 |
Secondary
Change in Steps Per Day From Baseline
Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period.
Time frame: baseline and Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Steps Per Day From Baseline | -1038 steps per day | Standard Deviation 1190 |
| Waitlist Control | Change in Steps Per Day From Baseline | -92 steps per day | Standard Deviation 2046 |
Secondary
Change in Total Percent Body Fat From Baseline
Baseline and post-study % body fat will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Change in Total Percent Body Fat From Baseline | -0.6 body fat percent | Standard Deviation 0.9 |
| Waitlist Control | Change in Total Percent Body Fat From Baseline | -0.3 body fat percent | Standard Deviation 1.5 |
Secondary
Change in Visceral Fat Mass From Baseline
Baseline and post-study visceral fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Time frame: up to 20 weeks
Population: Visceral fat mass was not measured for all scans on each participant, therefore due to the amount of missing data, the change in visceral fat mass could not be measured.
Secondary
Changes in Accelerometer-Measured Physical Activity From Baseline
Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period. Light intensity is Moderate intensity is Vigorous intensity is
Time frame: baseline and Week 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Activity | -41 minutes per week | Standard Deviation 72 |
| Strength-Training Intervention | Changes in Accelerometer-Measured Physical Activity From Baseline | Vigorous Activity | 0 minutes per week | Standard Deviation 3 |
| Strength-Training Intervention | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Vigorous Physical Activity (continuous minutes) | -41 minutes per week | Standard Deviation 72 |
| Strength-Training Intervention | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Vigorous Physical Activity in bouts greater than 10 minutes | -30 minutes per week | Standard Deviation 49 |
| Strength-Training Intervention | Changes in Accelerometer-Measured Physical Activity From Baseline | Light Activity | -77 minutes per week | Standard Deviation 200 |
| Waitlist Control | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Vigorous Physical Activity in bouts greater than 10 minutes | -8 minutes per week | Standard Deviation 41 |
| Waitlist Control | Changes in Accelerometer-Measured Physical Activity From Baseline | Light Activity | 5 minutes per week | Standard Deviation 306 |
| Waitlist Control | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Activity | 5 minutes per week | Standard Deviation 69 |
| Waitlist Control | Changes in Accelerometer-Measured Physical Activity From Baseline | Moderate Vigorous Physical Activity (continuous minutes) | 3 minutes per week | Standard Deviation 73 |
| Waitlist Control | Changes in Accelerometer-Measured Physical Activity From Baseline | Vigorous Activity | -2 minutes per week | Standard Deviation 9 |
Secondary
Changes in FACT-En From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Changes in FACT-En From Baseline | -0.0 score on a scale | Standard Deviation 5.1 |
| Waitlist Control | Changes in FACT-En From Baseline | 0.4 score on a scale | Standard Deviation 5.8 |
Secondary
Changes in FACT From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such.
Time frame: baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Changes in FACT From Baseline | -0.3 score on a scale | Standard Deviation 14 |
| Waitlist Control | Changes in FACT From Baseline | 0.6 score on a scale | Standard Deviation 13 |
Secondary
Changes in FACT Subscales From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Time frame: baseline and 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | Changes in FACT Subscales From Baseline | Physical | 0.4 score on a scale | Standard Deviation 2.7 |
| Strength-Training Intervention | Changes in FACT Subscales From Baseline | Social | -0.0 score on a scale | Standard Deviation 3.6 |
| Strength-Training Intervention | Changes in FACT Subscales From Baseline | Emotional | -0.4 score on a scale | Standard Deviation 3.3 |
| Strength-Training Intervention | Changes in FACT Subscales From Baseline | Functional | 0.3 score on a scale | Standard Deviation 2.8 |
| Waitlist Control | Changes in FACT Subscales From Baseline | Functional | -0.5 score on a scale | Standard Deviation 3.3 |
| Waitlist Control | Changes in FACT Subscales From Baseline | Physical | 0.5 score on a scale | Standard Deviation 2.5 |
| Waitlist Control | Changes in FACT Subscales From Baseline | Emotional | -0.1 score on a scale | Standard Deviation 3 |
| Waitlist Control | Changes in FACT Subscales From Baseline | Social | -0.7 score on a scale | Standard Deviation 3.8 |
Secondary
Changes in Mental Well-being From Baseline
Changes in mental well-being from baseline, mid-point, and post-study (including anxiety, depression, and fatigue) will be assessed using standardized NIH-provided Patient-Reported Outcome Measurement Information System (PROMIS) measures. The fatigue assessment asks about self-reported systems of fatigue and tiredness, all the way up to exhaustion overall, and ask about fatigue over the past seven days. The depression assessment asks about depressive symptoms over the past seven days. The anxiety assessment asks about symptoms adjacent-to and including anxiety over the past seven days. For each of these three instruments (which comprise the mental well-being assessments) the data will be reported as change over time, specifically using the T-score (standardized mean) and the standard error. Each is standardized to a mean of 50 and a range of 0-100; a higher scores indicate a higher level of that construct, whether it's higher levels of depression, fatigue or anxiety.
Time frame: baseline and Week 10
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | Changes in Mental Well-being From Baseline | Anxiety | -0.3 T-score | Standard Deviation 6.7 |
| Strength-Training Intervention | Changes in Mental Well-being From Baseline | Fatigue | -2.5 T-score | Standard Deviation 7.9 |
| Strength-Training Intervention | Changes in Mental Well-being From Baseline | Depression | -1.8 T-score | Standard Deviation 5 |
| Waitlist Control | Changes in Mental Well-being From Baseline | Anxiety | 1.5 T-score | Standard Deviation 6.6 |
| Waitlist Control | Changes in Mental Well-being From Baseline | Fatigue | -2.0 T-score | Standard Deviation 9.3 |
| Waitlist Control | Changes in Mental Well-being From Baseline | Depression | -0.8 T-score | Standard Deviation 5.4 |
Secondary
Changes in Self-Efficacy From Baseline
Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time.
Time frame: Baseline and 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Strength-Training Intervention | Changes in Self-Efficacy From Baseline | -3.4 score on a scale | Standard Deviation 19 |
| Waitlist Control | Changes in Self-Efficacy From Baseline | -6.0 score on a scale | Standard Deviation 14.7 |
Secondary
FACT Emotional Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Time frame: baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT Emotional Subscale Scores | Baseline | 21.1 score on a scale | Standard Deviation 2.7 |
| Strength-Training Intervention | FACT Emotional Subscale Scores | Week 5 | 21.4 score on a scale | Standard Deviation 2.4 |
| Strength-Training Intervention | FACT Emotional Subscale Scores | Week 10 | 20.8 score on a scale | Standard Deviation 3.8 |
| Waitlist Control | FACT Emotional Subscale Scores | Baseline | 20.4 score on a scale | Standard Deviation 3.3 |
| Waitlist Control | FACT Emotional Subscale Scores | Week 5 | 20.7 score on a scale | Standard Deviation 3.3 |
| Waitlist Control | FACT Emotional Subscale Scores | Week 10 | 20.2 score on a scale | Standard Deviation 3.4 |
Secondary
FACT-En Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements.
Time frame: baseline, 5 Weeks,10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT-En Scores | Baseline | 55.0 score on a scale | Standard Deviation 7.1 |
| Strength-Training Intervention | FACT-En Scores | Week 5 | 54.6 score on a scale | Standard Deviation 7.2 |
| Strength-Training Intervention | FACT-En Scores | Week 10 | 55.0 score on a scale | Standard Deviation 7.5 |
| Waitlist Control | FACT-En Scores | Baseline | 54.5 score on a scale | Standard Deviation 7.1 |
| Waitlist Control | FACT-En Scores | Week 5 | 54.7 score on a scale | Standard Deviation 5 |
| Waitlist Control | FACT-En Scores | Week 10 | 55.0 score on a scale | Standard Deviation 7 |
Secondary
FACT Functional Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Time frame: baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT Functional Subscale Scores | Baseline | 23.0 score on a scale | Standard Deviation 2.6 |
| Strength-Training Intervention | FACT Functional Subscale Scores | Week 5 | 22.9 score on a scale | Standard Deviation 3.2 |
| Strength-Training Intervention | FACT Functional Subscale Scores | Week 10 | 23.3 score on a scale | Standard Deviation 3.5 |
| Waitlist Control | FACT Functional Subscale Scores | Baseline | 21.6 score on a scale | Standard Deviation 5 |
| Waitlist Control | FACT Functional Subscale Scores | Week 5 | 21.7 score on a scale | Standard Deviation 5.3 |
| Waitlist Control | FACT Functional Subscale Scores | Week 10 | 21.0 score on a scale | Standard Deviation 6.3 |
Secondary
FACT Physical Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Time frame: baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT Physical Subscale Scores | Baseline | 24.4 score on a scale | Standard Deviation 2.3 |
| Strength-Training Intervention | FACT Physical Subscale Scores | Week 5 | 24.5 score on a scale | Standard Deviation 2.9 |
| Strength-Training Intervention | FACT Physical Subscale Scores | Week 10 | 24.8 score on a scale | Standard Deviation 2.9 |
| Waitlist Control | FACT Physical Subscale Scores | Baseline | 24.0 score on a scale | Standard Deviation 3.4 |
| Waitlist Control | FACT Physical Subscale Scores | Week 5 | 23.9 score on a scale | Standard Deviation 4.3 |
| Waitlist Control | FACT Physical Subscale Scores | Week 10 | 24.5 score on a scale | Standard Deviation 4.5 |
Secondary
FACT Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such.
Time frame: baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT Scores | baseline | 146 score on a scale | Standard Deviation 11.9 |
| Strength-Training Intervention | FACT Scores | Week 5 | 146 score on a scale | Standard Deviation 13.2 |
| Strength-Training Intervention | FACT Scores | Week 10 | 146 score on a scale | Standard Deviation 15 |
| Waitlist Control | FACT Scores | baseline | 141 score on a scale | Standard Deviation 21.7 |
| Waitlist Control | FACT Scores | Week 5 | 142 score on a scale | Standard Deviation 21.7 |
| Waitlist Control | FACT Scores | Week 10 | 140 score on a scale | Standard Deviation 26.1 |
Secondary
FACT Social Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Time frame: baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | FACT Social Subscale Scores | Baseline | 22.3 score on a scale | Standard Deviation 3.2 |
| Strength-Training Intervention | FACT Social Subscale Scores | Week 5 | 22.4 score on a scale | Standard Deviation 5 |
| Strength-Training Intervention | FACT Social Subscale Scores | Week 10 | 22.3 score on a scale | Standard Deviation 4.8 |
| Waitlist Control | FACT Social Subscale Scores | Baseline | 20.6 score on a scale | Standard Deviation 6.5 |
| Waitlist Control | FACT Social Subscale Scores | Week 5 | 20.8 score on a scale | Standard Deviation 6 |
| Waitlist Control | FACT Social Subscale Scores | Week 10 | 19.7 score on a scale | Standard Deviation 7.6 |
Secondary
Number of Participants Reporting Very or Extremely Satisfied With Intervention
Participants will complete semi-structured qualitative interviews with the study coordinator. Interviews will be recorded, transcribed and coded to identify content themes. These interviews will be used to collect qualitative information and overall satisfaction with the intervention, as well as areas to improve with future interventions and barriers to participation.
Time frame: At final visit - up to 20 weeks
Population: Satisfaction was only collected for the strength training intervention. Sixteen participants completed the end of study satisfaction survey upon which this metric was based.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Strength-Training Intervention | Number of Participants Reporting Very or Extremely Satisfied With Intervention | 16 Participants |
Secondary
Self-Efficacy Scores
Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training. This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time.
Time frame: Baseline, 5 weeks, 10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Strength-Training Intervention | Self-Efficacy Scores | baseline | 63.4 score on a scale | Standard Deviation 20.4 |
| Strength-Training Intervention | Self-Efficacy Scores | week 5 | 57.3 score on a scale | Standard Deviation 19 |
| Strength-Training Intervention | Self-Efficacy Scores | week 10 | 60.0 score on a scale | Standard Deviation 21.3 |
| Waitlist Control | Self-Efficacy Scores | baseline | 63.7 score on a scale | Standard Deviation 19.7 |
| Waitlist Control | Self-Efficacy Scores | week 5 | 58.3 score on a scale | Standard Deviation 20.3 |
| Waitlist Control | Self-Efficacy Scores | week 10 | 57.7 score on a scale | Standard Deviation 22.9 |