Breast Cancer Female
Conditions
Brief summary
The goal of this clinical trial is to learn how a group resistance training plan can improve body mobility and strength in female breast cancer patients who have completed their breast cancer treatment. The main questions it aims to answer are: * Is resistance training feasible following breast cancer treatment * Can it improve the body's mobility and strength lost as a result of the breast cancer treatment * can it improve the body's composition (for example muscle mass) * can resistance training increase one's activity level and help prevent weight gain, perhaps, lowering the risk of cancer recurrence. Participants will attend a group resistance training exercise group program, 3-4 times per week, under close supervision with monitoring a participant's ability to safely and effectively complete the program. The exercises include: lunges, squats and dead lifts.
Detailed description
Obesity and low muscle mass, i.e. poor body composition, is a risk factor for breast cancers and disease recurrence after treatment. Furthermore, weight gain during and after treatment for breast cancer is associated with higher risk of recurrence, distant metastases, and death. Activity levels have been repeatedly associated with a lower risk of cancer incidence, improved outcomes after cancer treatment and improved overall survival, yet the majority of breast cancer survivors do not meet adequate daily activity level recommendations. This protocol seeks to prospectively follow forty (40) female breast cancer patients (ages 20-95) during exercise who are post-cancer treatment and to assess the safety and feasibility of a monitored group exercise regimen utilizing high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment. This regimen is a standard of care regimen utilized in strength and conditioning protocols. The investigators hypothesize that an observed exercise regimen such as this will prove safe and feasible in women and may improve functional mobility, body composition and resting metabolic rate. The exercise regimen will utilize a mixture of compound movements utilizing mainly closed kinetic chain movements (CKC), focusing on exercises with the goal of improving physical and metabolic function, mobility, muscle mass and body composition utilizing guidelines from the National Strength and Conditioning Association (NSCA). CKC exercises include lunges, squats, and dead lifts.
Interventions
OTHERObservation of Exercise Program Adherence
Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program.
Sponsors
Colin Champ, MD
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20-89 years 2. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast 3. Women must have undergone breast conservation therapy with no neoadjuvant or adjuvant chemotherapy (adjuvant endocrine therapy is permitted) 4. Participants must have abstained from smoking for at least 12 months 5. Women of child-bearing potential must have had a pregnancy test prior to initiation of radiation therapy (standard protocol for radiation therapy); verbally confirm lack of pregnancy prior to enrollment; and, consent to use adequate contraception during the course of the study. 6. Participants must be determined capable of engaging in resistance training. 7. Participants must have a schedule amenable to three prescheduled workout sessions per week, scheduled during the day. 8. Participants must complete a Functional Mobility Screen (FMS) and be determined safe to engage in the workout regimen by the study exercise personnel. 9. Participants must be determined capable of engaging in group resistance training sessions by exercise personnel and/or study PI 10. Participants must be able to get down and up from the ground and squat their body weight.
Exclusion criteria
1. Any treatment with chemotherapy for breast cancer 2. Inability to get and down off the ground or squat body weight 3. Inability to safely engage in group sessions 4. Severe arthritic, joint, cardiovascular, or musculoskeletal condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Strength From Baseline Through Study Completion, up to 3 Months | Baseline and months 1, 2, and 3 | Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3. |
| Session Attendance | Baseline and Three (3) months | Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%. |
| Change in Adipose Tissue (InBody, kg) | Baseline and Three (3) months | Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR). |
| Change in Adipose Tissue (Ultrasound, Lbs) | Baseline and Three (3) months | Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR). |
| Change in Muscle Mass | Baseline and Three (3) months | Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months. |
| Change in Fat-Free Mass | Baseline and Three (3) months | Changes in percent fat-free mass (measured by ultrasound) from baseline to three months. |
| Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | Baseline and Three (3) months | EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine. |
| Activity Levels Via Godin Questionnaire | 3 months | Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary |
| Resting Metabolic Rate as Calories Burned Per Day | Baseline and Three (3) months | Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis. |
| Functional Movement Screen | Baseline and Three (3) months | A functional movement screen will be performed pre and post regimen to assess change in overall score Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of if any pain felt by the subject during the movement, subject is unable to perform the movement, subject performs the movement through compensatory movements, and subject performs the movement correctly, respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome. |
| Y-balance Score | Baseline and Three (3) months | A Y-balance test will be performed pre and post regimen to assess change Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Will Undergo an Assessment 1 Year Following the Exercise Program. | 12 months | Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility |
Countries
United States
Participant flow
Pre-assignment details
There were 54 total patients screened for eligibility (Fig. 2). There were 9 patients who chose not to participate due to scheduling conflicts There were 2 patients screened who were referred to PT due to joint & musculoskeletal conditions precluding safe training
Participants by arm
| Arm | Count |
|---|---|
| Standard High-load Resistance Training Standard exercise regimen utilizes a mixture of compound and isolated movements, focusing on compound exercises. The regimen is a typical standard of care resistance training program and sports performance and strength and conditioning facilities. The observed classes will take place three times per week. Warm-up exercises focused on mobility, flexibility and core activation will be performed to reduce the risk of injury. Each individual exercise workout will generally progress from most intense, CKC, compound, and athletic movements to least intense throughout the workout to maximize safety. Additionally, each workout will provide full body resistance training to focus on functional exercises, intensity, and efficiency. Each workout will take approximately 45 minutes. The total exercise regimen will last 3 months.
Observation of Exercise Program Adherence: Observation of a monitored group exercise regimen utilizing standard of care high-load resistance training and functional exercises with compound movements under close supervision and with the goal of improving functional mobility, body composition, and strength after cancer treatment to study adherence and attendance to the exercise program. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Standard High-load Resistance Training | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 43 Participants | — |
| Age, Continuous | 56.5 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 43 participants | — |
| Sex: Female, Male Female | 43 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
Primary
Activity Levels Via Godin Questionnaire
Change in activity levels measured by Godin Questionnaire pre and post regimen, specifically strenuous, moderate and mild/light exercise with a score from 0 to unlimited. The Godin scale score lists 24 or more units of exercise as active, 14-23 units as moderately active, and less than 14 units as insufficiently active/sedentary
Time frame: 3 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Activity Levels Via Godin Questionnaire | Post-intervention | 41.5 score on a scale |
| Standard High-load Resistance Training | Activity Levels Via Godin Questionnaire | Baseline | 23.5 score on a scale |
Primary
Change in Adipose Tissue (InBody, kg)
Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis. Values reported are median changes with interquartile range (IQR).
Time frame: Baseline and Three (3) months
Population: Participants whose change in adipose tissue was measured.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Change in Adipose Tissue (InBody, kg) | Baseline | 30.7 kg |
| Standard High-load Resistance Training | Change in Adipose Tissue (InBody, kg) | Post-Intervention | 28.2 kg |
Primary
Change in Adipose Tissue (Ultrasound, Lbs)
Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound. Values reported are median changes with interquartile range (IQR).
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Change in Adipose Tissue (Ultrasound, Lbs) | Baseline | 37.4 percentage of Body Fat |
| Standard High-load Resistance Training | Change in Adipose Tissue (Ultrasound, Lbs) | Post-Intervention | 32.6 percentage of Body Fat |
Primary
Change in Fat-Free Mass
Changes in percent fat-free mass (measured by ultrasound) from baseline to three months.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Change in Fat-Free Mass | InBody fat Free Mass Post-intervention | 46.9 kg |
| Standard High-load Resistance Training | Change in Fat-Free Mass | InBody fat Free Mass Baseline | 45.9 kg |
Primary
Change in Muscle Mass
Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) from baseline to three months.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Change in Muscle Mass | InBody Muscle Mass Baseline | 25.0 kg |
| Standard High-load Resistance Training | Change in Muscle Mass | InBody Muscle Mass Post-intervention | 25.6 kg |
Primary
Changes in Strength From Baseline Through Study Completion, up to 3 Months
Strength will be calculated via load lifted throughout the entire regimen as weight x repetitions x sets at the end of months 1, 2, and 3.
Time frame: Baseline and months 1, 2, and 3
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Split Squat, Month 1 (Week 4) | 192 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Split Squat, Month 2 (Week 4) | 383 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Split Squat, Month 3 (Week 4) | 383 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Trap Bar Deadlift, Month 1 (Week 4) | 1131 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Trap Bar Deadlift, Month 2 (Week 4) | 1210 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Load Trap Bar Deadlift, Month 3 (Week 4) | 1415 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Incline Dumbbell Bench, Month 1 (Week 4) | 170 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Incline Dumbbell Bench, Month 2 (Week 4) | 261 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Incline Dumbbell Bench, Month 3 (Week 4) | 272 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Bird Dog Row, Month 1 (Week 4) | 204 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Bird Dog Row, Month 2 (Week 4) | 272 Load (kilograms x Repetitions x Sets) |
| Standard High-load Resistance Training | Changes in Strength From Baseline Through Study Completion, up to 3 Months | Bird Dog Row, Month 3 (Week 4) | 340 Load (kilograms x Repetitions x Sets) |
Primary
Functional Movement Screen
A functional movement screen will be performed pre and post regimen to assess change in overall score Functional movement screen (FMS) total score for the 7 movement patterns assessed by an examiner ranges from 0 to 21. A score below 14 is felt to identify individuals at risk of injury. This is calculated by assigning scores of 0 (minimum), 1, 2, and 3 (maximum) to the response categories of if any pain felt by the subject during the movement, subject is unable to perform the movement, subject performs the movement through compensatory movements, and subject performs the movement correctly, respectively. A score below 14 is felt to identify individuals at risk of injury. Higher scores mean a better outcome.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Functional Movement Screen | Baseline | 9 score on a scale |
| Standard High-load Resistance Training | Functional Movement Screen | Post-intervention | 12 score on a scale |
Primary
Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) test pre and post regimen. This test is a descriptive system that is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There is an additional question measuring an individual's current overall health-related quality of life. Total score for the 5 questions ranges from 5 (no problems on any dimension) to 25 (extreme problems on all dimensions). Calculated by assigning scores of 1 (minimum), 2, 3, 4, and 5 (maximum), to the response categories of no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively. Higher scores mean worse outcomes. There is an additional question scored from 0 to 100 recorded for their current overall health-related quality of life. 100 means the best health and 0 means the worst health they can imagine.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 2 Self-Care Score Post-Intervention | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 3 Usual Activities Score Baseline | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 4 Pain / Discomfort Score Post-Intervention | 4 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 6 Current Overall Health-Related Quality of Life Score Baseline | 73.5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 1: Mobility Score Baseline | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 1: Mobility Score Post-Intervention | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 2 Self-Care Score Baseline | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 3 Usual Activities Score Post-Intervention | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 4 Pain / Discomfort Score Baseline | 4 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 5 Anxiety / Depression Score Baseline | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 5 Anxiety / Depression Score Post-Intervention | 5 score on a scale |
| Standard High-load Resistance Training | Quality of Life Via the EuroQol Group Survey EuroQol-5 Dimensions-5 Levels | EuroQol 5 Dimension 6 Current Overall Health-Related Quality of Life Score Post-Intervention | 85 score on a scale |
Primary
Resting Metabolic Rate as Calories Burned Per Day
Change in resting metabolic rate (RMR) pre and post regimen measured via ultrasound and bioimpedance analysis.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Resting Metabolic Rate as Calories Burned Per Day | InBody RMR Post-intervention | 1381.5 kcal |
| Standard High-load Resistance Training | Resting Metabolic Rate as Calories Burned Per Day | InBody RMR Baseline | 1365.5 kcal |
| Standard High-load Resistance Training | Resting Metabolic Rate as Calories Burned Per Day | US RMR Baseline | 1403 kcal |
| Standard High-load Resistance Training | Resting Metabolic Rate as Calories Burned Per Day | US RMR Post-intervention | 1437 kcal |
Primary
Session Attendance
Calculated as the percentage of participants completing at least 75% of the planned exercise sessions. Dropout rate, defined as individuals who quit the workout regimen altogether, is expected to be less 20%.
Time frame: Baseline and Three (3) months
Population: Participants who completed at least 75% of the planned exercise sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard High-load Resistance Training | Session Attendance | 39 Participants |
Primary
Y-balance Score
A Y-balance test will be performed pre and post regimen to assess change Y-balance score adds up the distance each leg can move in the front and side directions, divided by the length of the hip. This correlates inversely with fall risk.
Time frame: Baseline and Three (3) months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard High-load Resistance Training | Y-balance Score | Baseline Left Side | 72.3 ratio |
| Standard High-load Resistance Training | Y-balance Score | Post-intervention Left Side | 83.9 ratio |
| Standard High-load Resistance Training | Y-balance Score | Baseline Right Side | 73.0 ratio |
| Standard High-load Resistance Training | Y-balance Score | Post-intervention Right Side | 86.2 ratio |
Secondary
Participants Will Undergo an Assessment 1 Year Following the Exercise Program.
Participants will be assessed 1 year following exercises as they were at baseline and post exercise as Standard of Care (SOC). The SOC assessments will encompass weight, height, BMI, body composition, resting metabolic rate, quality of life questionnaires and exercise forms, strength, and mobility
Time frame: 12 months