Cardiorenal; Change, Cardiovascular Diseases, Kidney Transplant; Complications, Physical Activity
Conditions
Keywords
Kidney transplant, SystemCHANGE, physical activity, smart phone, Fitbit, activity monitor, step count, post-surgery, quality of life, cardiovascular
Brief summary
Inactivity is a common problem among older kidney transplant recipients (KTRs) and is associated with their high incidence of obesity and cardiovascular problems which are the leading cause of death for KTRs. However, the combination of SystemCHANGE activity trackers holds promise for increasing physical activity of KTR patients post-surgery. This pilot study will incorporate Fitbit health trackers with an intervention of questions about influences to physical activity in a population of kidney transplant recipients who are at particularly high risk of cardiovascular disease and death.
Detailed description
This is a randomized study with intervention and control arms of sixty kidney transplant recipients age 60 and older. Demographic information will be collected during the screening phone call and will include: gender, race, marital status, income, education, transplant date, prescribed medications, type of diet, smoking status, and co-morbidities. All study data will be entered directly into electronic research forms using REDCap. Overview of Intervention and Control Groups: Intervention and control groups will be enrolled in the study in the same manner, receive the same instruction on use of the Fitbit and have the same number of study contacts. Group sessions will be held at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Intervention Group Active Phase, Group Session 1 (1 hour, 20 minutes): Research staff will demonstrate proper Fitbit activity tracker use, set up the smartphone application, and assist entry of daily step goals into the smartphone application. Fitbits will be set up with Gmail accounts with unique unidentifiable codes. Participants will be taught how to sync to their smartphone and retrieve data from their Fitbit. One week following this session, participants will be called to troubleshoot problems and be encourage to increase their step goal 5% each month (total phone time 15 minutes). Intervention/Control Group Timeline: Intervention Active Phase, Group Session 2 (1 hour): Fitbit activity tracker reports will be reviewed by research staff with participants. SystemCHANGE concepts will be discussed such as opportunities for improvement and possibilities for doing better. A SystemCHANGE powerpoint will outline components and participants will be placed in groups of 5 where researchers will guide participants through the 4 steps of SystemCHANGE. Participants will be asked to identify important people that influence their physical activity, which habits or activity occur daily, weekly, or monthly, and how these habits and people impact physical activity. Participants will also include things that influence their participation in physical activity (e.g., availability of facilities as a walking path getting home from work late, or sleeping late on a weekend). Social activities and any rituals associated with physical activity such as gardening, housecleaning, shopping, and hobbies will also be noted. Research staff will place the routines (daily, weekly, monthly) into a graphic format that helps participants understand how routines are related to each other and can work for, or against, changing physical activity behavior. These cycles will be discussed to help understanding of how a routine involving family demands, for example, may influence participation in physical activity. Goals for increasing steps will be made, (generally, a 5% increase) and use of their activity tracker reports for monitoring progress toward improvement will be discussed and demonstrated. In this session and throughout, participants will be encouraged to look beyond personal motivation and explore their life routines and the people who shape those routines. Intervention Active Phase, Group Sessions 3-7 (1 hour/session): Prior to each session, the participants' activity tracker reports will be given to them and reviewed during the group session. Participants will be asked what they are learning about their physical activity and what changes they want to make. Participants will be asked to describe their improvements and be encouraged to continue using the activity tracker for the next 6 months during the maintenance phase. Intervention Maintenance (6 months): At the final monthly session, participants will be instructed to continue until month 12. Control Group Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will NOT be asked to increase their step goal 5% each month based on the step-data received from baseline to week 1. Session 2 will be used to troubleshoot and discuss any problems with the Fitbit activity trackers. In later sessions, educational information about healthy living as a transplant recipient will be presented, including topics such as diet, taking medication, risk for skin cancer, gastrointestinal side effects, dental care, and new onset post-transplant diabetes. The meeting time will be equivalent to those of the intervention group The maintenance phase will last 6 months. At month 7, just as the intervention group, participants will be reminded to continue their use of the Fitbit activity tracker and that the research team will not be in contact with them for 6 months. There will be a final meeting at month 12. Study staff will provide assistance as needed by reading questions to participants. Outcome data from both study groups will be collected at the appropriate sessions. Retention: Text messages will be sent to participants during months when they are not attending a face-to-face session to provide encouragement and reinforcement for their participation in the study. In addition, phone calls will be made by research staff during each month to each participant to provide updates on their progress in the study as well as encouragement and support. Participants who complete the study will be allowed to keep their activity tracker.
Interventions
Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.
Sponsors
Study design
Intervention model description
Participants in the intervention group will receive the combination of the SystemCHANGE and activity tracker intervention while participants in the control group will use activity trackers only. Intervention and control groups will receive the same instruction on use of the activity tracker, and have the same number of study contacts.
Eligibility
Inclusion criteria
* Kidney transplant recipient at The Ohio State University Wexner Medical Center, Kidney Transplant Program * Age 60 or older * Received clearance from healthcare provider to participate * Ability to speak, read, and hear English * Possession or ready-access to a smart phone capable of accessing mobile activity tracker data * Lacks cognitive impairment (verified by mini cognition test) * Able to walk without an assist device (cane or walker) * Not currently hospitalized * Greater than 3 months post- transplant
Exclusion criteria
* Currently on dialysis * Currently participating in a weight loss program * Currently participating in a structured exercise program * Currently wearing/using an activity tracker * Planning to relocate out of the Columbus area in the next 6 months or less
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps Taken Per Day by Using an Activity Tracker | (T2) 3months, (T3) 6months, & (T4)12 months | Steps were averaged per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Blood Pressure | (T2) 3months, (T3) 6months, & (T4)12 months | Resting blood pressure will be measured on each participant in a seated position using a Withings blood pressure cuff by the research staff. The research staff collecting the resting blood pressure reading will be a registered nurse. The research staff collecting the readings will be blinded to the study groups. |
| Quality of Life: Physical (Functional) and Mental (Well-being) Health | (T2) 3months, (T3) 6months, & (T4)12 months | Physical and mental component scores, ranging from 0 (lowest level of health) to 100 (highest level of health), are derived from the individual items and was used as study outcomes. |
| Weight (Pounds) | (T2) 3months, (T3) 6months, & (T4)12 months | Weight was measured without shoes and in light clothing using a digital scale. |
| Six Minute Walk Test | (T2) 3months, (T3) 6months, & (T4)12 months | A section of 98 feet was marked off on a hard flat surface using two orange cones. Participants were asked to walk at a comfortable pace for 6-minutes between the cones while being timed, and the distance walked was recorded in feet. |
| Body Mass Index (BMI)kg/m2 | (T2) 3months, (T3) 6months, & (T4)12 months | Body mass index (BMI; kg/m2) will be calculated as \[mass (lb)/ height (in)2 x 703 |
| Health Outcome: Waist Circumference (cm) | (T2) 3months, (T3) 6months, & (T4)12 months | Waist circumference (WC) will be obtained by measuring the individual's circumference halfway between the illac crest and the lower anterior ribs with the person standing upright during expiration. |
| Radial Pulse (Beats Per Minute) | (T2) 3months, (T3) 6months, & (T4)12 months | The research staff will obtain a radial pulse (heart rate) over a 60-second count while the participant remains seated. The research staff collecting the radial pulse reading will be a registered nurse and blinded to the study groups. |
Countries
United States
Participant flow
Pre-assignment details
There was no pre-assignment.
Participants by arm
| Arm | Count |
|---|---|
| Control This arm includes participants randomized to the control group who will use activity trackers (Fitbits) only, and not receive the SystemCHANGE intervention.
Fitbit (Control): Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session. | 26 |
| Intervention This are includes participants randomize to the intervention group who will receive the combination of the SystemCHANGE and activity tracker intervention
SystemCHANGE and Fitbit (Intervention): Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes.. | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 7 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 15 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 12 Participants | 27 Participants |
| Age, Continuous | 65.1 years STANDARD_DEVIATION 4 | 65.7 years STANDARD_DEVIATION 4.9 | 65.4 years STANDARD_DEVIATION 4.4 |
| Body mass index | 30.5 kg/m^2 STANDARD_DEVIATION 5.2 | 31.1 kg/m^2 STANDARD_DEVIATION 5.9 | 30.8 kg/m^2 STANDARD_DEVIATION 5.5 |
| Diastolic Blood Pressure (mmHg | 79.64 mmHg STANDARD_DEVIATION 10.02 | 80.16 mmHg STANDARD_DEVIATION 14.82 | 80.1 mmHg STANDARD_DEVIATION 12.4 |
| Heart Rate (beats per minute) | 74.36 beats per minute STANDARD_DEVIATION 10.83 | 70.68 beats per minute STANDARD_DEVIATION 10.36 | 72.62 beats per minute STANDARD_DEVIATION 10.4 |
| Quality of Life Mental Health | 54.61 scores on a scale ranging from 0 - 100 STANDARD_DEVIATION 9.38 | 53.68 scores on a scale ranging from 0 - 100 STANDARD_DEVIATION 9.17 | 54.1 scores on a scale ranging from 0 - 100 STANDARD_DEVIATION 9.2 |
| Quality of Life Physical Function | 43.03 scores on a scale, ranging from 0-100 STANDARD_DEVIATION 10.07 | 41.53 scores on a scale, ranging from 0-100 STANDARD_DEVIATION 9.49 | 42.3 scores on a scale, ranging from 0-100 STANDARD_DEVIATION 9.78 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 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 | 14 Participants | 16 Participants | 30 Participants |
| Region of Enrollment United States | 26 participants | 27 participants | 53 participants |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 23 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 30 Participants |
| Steps per Day | 4171 steps per day STANDARD_DEVIATION 1709 | 4432 steps per day STANDARD_DEVIATION 1865 | 4302 steps per day STANDARD_DEVIATION 1787 |
| Systolic Blood Pressure | 150.2 mmHg STANDARD_DEVIATION 19.05 | 141.8 mmHg STANDARD_DEVIATION 24.28 | 146 mmHg STANDARD_DEVIATION 21.66 |
| Waist Circumference (centimeters | 40.94 centimeters STANDARD_DEVIATION 5.13 | 40.54 centimeters STANDARD_DEVIATION 5.21 | 40.6 centimeters STANDARD_DEVIATION 5.18 |
| Weight (pounds) | 194.4 pounds STANDARD_DEVIATION 40.84 | 189.4 pounds STANDARD_DEVIATION 36.3 | 191.6 pounds STANDARD_DEVIATION 38.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 |
Outcome results
Steps Taken Per Day by Using an Activity Tracker
Steps were averaged per day.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: Descriptive statistics were used to analyze the monthly average for daily steps at 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Steps Taken Per Day by Using an Activity Tracker | (T2) 3months | 4710 average of steps per day | Standard Deviation 2628 |
| Control | Steps Taken Per Day by Using an Activity Tracker | (T3) 6months | 4157 average of steps per day | Standard Deviation 2931 |
| Control | Steps Taken Per Day by Using an Activity Tracker | (T4) 12months | 3608 average of steps per day | Standard Deviation 2985 |
| Intervention | Steps Taken Per Day by Using an Activity Tracker | (T2) 3months | 5708 average of steps per day | Standard Deviation 3586 |
| Intervention | Steps Taken Per Day by Using an Activity Tracker | (T3) 6months | 4981 average of steps per day | Standard Deviation 3028 |
| Intervention | Steps Taken Per Day by Using an Activity Tracker | (T4) 12months | 4766 average of steps per day | Standard Deviation 3114 |
Body Mass Index (BMI)kg/m2
Body mass index (BMI; kg/m2) will be calculated as \[mass (lb)/ height (in)2 x 703
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: Mixed-effects linear regression modeling was used to model the BMI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Body Mass Index (BMI)kg/m2 | (T2) 3 months kg/m2 | 30.3 kg/m2 | Standard Error 5.5 |
| Control | Body Mass Index (BMI)kg/m2 | (T3) 6 months kg/m2 | 29.5 kg/m2 | Standard Error 4.6 |
| Control | Body Mass Index (BMI)kg/m2 | (T4) 12months kg/m2 | 28.4 kg/m2 | Standard Error 4.4 |
| Intervention | Body Mass Index (BMI)kg/m2 | (T2) 3 months kg/m2 | 31.3 kg/m2 | Standard Error 6.1 |
| Intervention | Body Mass Index (BMI)kg/m2 | (T3) 6 months kg/m2 | 30.7 kg/m2 | Standard Error 6.4 |
| Intervention | Body Mass Index (BMI)kg/m2 | (T4) 12months kg/m2 | 29.5 kg/m2 | Standard Error 8.1 |
Health Outcome: Waist Circumference (cm)
Waist circumference (WC) will be obtained by measuring the individual's circumference halfway between the illac crest and the lower anterior ribs with the person standing upright during expiration.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: We used mixed-effects linear regression modeling to derive estimates for each the WC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Health Outcome: Waist Circumference (cm) | (T2) 3 Months (cm) | 39.76 cm | Standard Deviation 5.24 |
| Control | Health Outcome: Waist Circumference (cm) | (T3) 6 Months (cm) | 39.08 cm | Standard Deviation 4.92 |
| Control | Health Outcome: Waist Circumference (cm) | (T4) 12 Months (cm) | 38.42 cm | Standard Deviation 4.66 |
| Intervention | Health Outcome: Waist Circumference (cm) | (T2) 3 Months (cm) | 39.22 cm | Standard Deviation 5 |
| Intervention | Health Outcome: Waist Circumference (cm) | (T3) 6 Months (cm) | 38.68 cm | Standard Deviation 5.02 |
| Intervention | Health Outcome: Waist Circumference (cm) | (T4) 12 Months (cm) | 38.70 cm | Standard Deviation 5.42 |
Quality of Life: Physical (Functional) and Mental (Well-being) Health
Physical and mental component scores, ranging from 0 (lowest level of health) to 100 (highest level of health), are derived from the individual items and was used as study outcomes.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: We used mixed-effects linear regression modeling to derive estimates for the quality of life.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T2) 3 months Physical Function | 45.32 score from 0-100 | Standard Deviation 7.84 |
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T3) 6 months Physical Function | 44.69 score from 0-100 | Standard Deviation 9.25 |
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T4) 12 months Physical Function | 45.71 score from 0-100 | Standard Deviation 7.93 |
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T2) 3 months | 53.50 score from 0-100 | Standard Deviation 8.03 |
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T3) 6 month | 53.12 score from 0-100 | Standard Deviation 9.87 |
| Control | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T4) 12 months | 50.91 score from 0-100 | Standard Deviation 10.69 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T3) 6 month | 51.30 score from 0-100 | Standard Deviation 8.21 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T2) 3 months Physical Function | 40.37 score from 0-100 | Standard Deviation 9.34 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T2) 3 months | 54.68 score from 0-100 | Standard Deviation 8.51 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T3) 6 months Physical Function | 40.91 score from 0-100 | Standard Deviation 9.97 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life Mental Health ( T4) 12 months | 51.56 score from 0-100 | Standard Deviation 9.93 |
| Intervention | Quality of Life: Physical (Functional) and Mental (Well-being) Health | Quality of Life (T4) 12 months Physical Function | 40.02 score from 0-100 | Standard Deviation 8.18 |
Radial Pulse (Beats Per Minute)
The research staff will obtain a radial pulse (heart rate) over a 60-second count while the participant remains seated. The research staff collecting the radial pulse reading will be a registered nurse and blinded to the study groups.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: We used mixed-effects linear regression modeling to derive estimates the resting heart rate.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Radial Pulse (Beats Per Minute) | (T3) 3 months(beats per minute) | 70.20 (beats per minute) | Standard Deviation 12.11 |
| Control | Radial Pulse (Beats Per Minute) | (T3) 6 months(beats per minute) | 70.20 (beats per minute) | Standard Deviation 11.11 |
| Control | Radial Pulse (Beats Per Minute) | (T4) 12 months(beats per minute) | 67.21 (beats per minute) | Standard Deviation 8.2 |
| Intervention | Radial Pulse (Beats Per Minute) | (T3) 3 months(beats per minute) | 69.08 (beats per minute) | Standard Deviation 8.82 |
| Intervention | Radial Pulse (Beats Per Minute) | (T3) 6 months(beats per minute) | 67.56 (beats per minute) | Standard Deviation 11.3 |
| Intervention | Radial Pulse (Beats Per Minute) | (T4) 12 months(beats per minute) | 66.82 (beats per minute) | Standard Deviation 7.76 |
Resting Blood Pressure
Resting blood pressure will be measured on each participant in a seated position using a Withings blood pressure cuff by the research staff. The research staff collecting the resting blood pressure reading will be a registered nurse. The research staff collecting the readings will be blinded to the study groups.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: We used mixed-effects linear regression modeling to derive estimates for the resting blood pressure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Resting Blood Pressure | (T4) 12 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 77.38 (mmHg) | Standard Deviation 10.21 |
| Control | Resting Blood Pressure | (T2) 3 months Systolic Blood Pressure (Unit of Measure: mmHg) | 146.7 (mmHg) | Standard Deviation 18.61 |
| Control | Resting Blood Pressure | (T2) 3 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 80.52 (mmHg) | Standard Deviation 12.73 |
| Control | Resting Blood Pressure | (T3) 6 months Systolic Blood Pressure (Unit of Measure: mmHg) | 142.2 (mmHg) | Standard Deviation 12.76 |
| Control | Resting Blood Pressure | (T3) 6 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 77.20 (mmHg) | Standard Deviation 8.94 |
| Control | Resting Blood Pressure | (T4) 12 months Systolic Blood Pressure (Unit of Measure: mmHg) | 143.8 (mmHg) | Standard Deviation 16.59 |
| Intervention | Resting Blood Pressure | (T3) 6 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 78.80 (mmHg) | Standard Deviation 13.1 |
| Intervention | Resting Blood Pressure | (T4) 12 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 74.05 (mmHg) | Standard Deviation 10.19 |
| Intervention | Resting Blood Pressure | (T3) 6 months Systolic Blood Pressure (Unit of Measure: mmHg) | 143.3 (mmHg) | Standard Deviation 19.69 |
| Intervention | Resting Blood Pressure | (T2) 3 months Systolic Blood Pressure (Unit of Measure: mmHg) | 140.7 (mmHg) | Standard Deviation 26.54 |
| Intervention | Resting Blood Pressure | (T4) 12 months Systolic Blood Pressure (Unit of Measure: mmHg) | 132.2 (mmHg) | Standard Deviation 14.8 |
| Intervention | Resting Blood Pressure | (T2) 3 months Diastolic Blood Pressure (Unit of Measure: mmHg) | 79.52 (mmHg) | Standard Deviation 14.47 |
Six Minute Walk Test
A section of 98 feet was marked off on a hard flat surface using two orange cones. Participants were asked to walk at a comfortable pace for 6-minutes between the cones while being timed, and the distance walked was recorded in feet.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: Mixed-effects linear regression modeling was used to model the Six Minute Walk Test as a linear combination of the fixed-effects of group (intervention vs. attention-control).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Six Minute Walk Test | (T2) 3Months | 1142 Feet | Standard Deviation 337.1 |
| Control | Six Minute Walk Test | (T3) 6 Months | 1204 Feet | Standard Deviation 266.6 |
| Control | Six Minute Walk Test | (T4) 12 Months | 1146 Feet | Standard Deviation 264.7 |
| Intervention | Six Minute Walk Test | (T2) 3Months | 1158 Feet | Standard Deviation 235.9 |
| Intervention | Six Minute Walk Test | (T3) 6 Months | 1142 Feet | Standard Deviation 295 |
| Intervention | Six Minute Walk Test | (T4) 12 Months | 1120 Feet | Standard Deviation 259.4 |
Weight (Pounds)
Weight was measured without shoes and in light clothing using a digital scale.
Time frame: (T2) 3months, (T3) 6months, & (T4)12 months
Population: We used mixed-effects linear regression modeling to derive estimates for the weight.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Weight (Pounds) | (T2) 3 months (pounds) | 193.1 pounds | Standard Deviation 36.63 |
| Control | Weight (Pounds) | (T6) 6 months (pounds) | 192.6 pounds | Standard Deviation 36.06 |
| Control | Weight (Pounds) | (T4) 12 months (pounds) | 189.0 pounds | Standard Deviation 35.91 |
| Intervention | Weight (Pounds) | (T2) 3 months (pounds) | 188.5 pounds | Standard Deviation 37.11 |
| Intervention | Weight (Pounds) | (T6) 6 months (pounds) | 186.6 pounds | Standard Deviation 37.67 |
| Intervention | Weight (Pounds) | (T4) 12 months (pounds) | 189.3 pounds | Standard Deviation 37.17 |