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Increasing Activity Post-Kidney Transplant With SystemCHANGE

Increasing Activity Post-Kidney Transplant With SystemCHANGE

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03191630
Acronym
CHANGE
Enrollment
60
Registered
2017-06-19
Start date
2017-10-01
Completion date
2020-04-30
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorenal; Change, Cardiovascular Diseases, Kidney Transplant; Complications, Physical Activity

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

BEHAVIORALFitbit (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.

BEHAVIORALSystemCHANGE 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. Participants will continue for months, after which time there will be a final group session.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Nursing Research (NINR)
CollaboratorNIH
Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Steps Taken Per Day by Using an Activity Tracker(T2) 3months, (T3) 6months, & (T4)12 monthsSteps were averaged per day.

Secondary

MeasureTime frameDescription
Resting Blood Pressure(T2) 3months, (T3) 6months, & (T4)12 monthsResting 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 monthsPhysical 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 monthsWeight was measured without shoes and in light clothing using a digital scale.
Six Minute Walk Test(T2) 3months, (T3) 6months, & (T4)12 monthsA 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 monthsBody 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 monthsWaist 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 monthsThe 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

ArmCount
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
Total53

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up77

Baseline characteristics

CharacteristicControlInterventionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants15 Participants26 Participants
Age, Categorical
Between 18 and 65 years
15 Participants12 Participants27 Participants
Age, Continuous65.1 years
STANDARD_DEVIATION 4
65.7 years
STANDARD_DEVIATION 4.9
65.4 years
STANDARD_DEVIATION 4.4
Body mass index30.5 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 (mmHg79.64 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 Health54.61 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 Function43.03 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 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants10 Participants20 Participants
Race (NIH/OMB)
More than one race
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants16 Participants30 Participants
Region of Enrollment
United States
26 participants27 participants53 participants
Sex: Female, Male
Female
7 Participants16 Participants23 Participants
Sex: Female, Male
Male
19 Participants11 Participants30 Participants
Steps per Day4171 steps per day
STANDARD_DEVIATION 1709
4432 steps per day
STANDARD_DEVIATION 1865
4302 steps per day
STANDARD_DEVIATION 1787
Systolic Blood Pressure150.2 mmHg
STANDARD_DEVIATION 19.05
141.8 mmHg
STANDARD_DEVIATION 24.28
146 mmHg
STANDARD_DEVIATION 21.66
Waist Circumference (centimeters40.94 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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 27
other
Total, other adverse events
0 / 260 / 27
serious
Total, serious adverse events
0 / 260 / 27

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlSteps Taken Per Day by Using an Activity Tracker(T2) 3months4710 average of steps per dayStandard Deviation 2628
ControlSteps Taken Per Day by Using an Activity Tracker(T3) 6months4157 average of steps per dayStandard Deviation 2931
ControlSteps Taken Per Day by Using an Activity Tracker(T4) 12months3608 average of steps per dayStandard Deviation 2985
InterventionSteps Taken Per Day by Using an Activity Tracker(T2) 3months5708 average of steps per dayStandard Deviation 3586
InterventionSteps Taken Per Day by Using an Activity Tracker(T3) 6months4981 average of steps per dayStandard Deviation 3028
InterventionSteps Taken Per Day by Using an Activity Tracker(T4) 12months4766 average of steps per dayStandard Deviation 3114
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlBody Mass Index (BMI)kg/m2(T2) 3 months kg/m230.3 kg/m2Standard Error 5.5
ControlBody Mass Index (BMI)kg/m2(T3) 6 months kg/m229.5 kg/m2Standard Error 4.6
ControlBody Mass Index (BMI)kg/m2(T4) 12months kg/m228.4 kg/m2Standard Error 4.4
InterventionBody Mass Index (BMI)kg/m2(T2) 3 months kg/m231.3 kg/m2Standard Error 6.1
InterventionBody Mass Index (BMI)kg/m2(T3) 6 months kg/m230.7 kg/m2Standard Error 6.4
InterventionBody Mass Index (BMI)kg/m2(T4) 12months kg/m229.5 kg/m2Standard Error 8.1
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlHealth Outcome: Waist Circumference (cm)(T2) 3 Months (cm)39.76 cmStandard Deviation 5.24
ControlHealth Outcome: Waist Circumference (cm)(T3) 6 Months (cm)39.08 cmStandard Deviation 4.92
ControlHealth Outcome: Waist Circumference (cm)(T4) 12 Months (cm)38.42 cmStandard Deviation 4.66
InterventionHealth Outcome: Waist Circumference (cm)(T2) 3 Months (cm)39.22 cmStandard Deviation 5
InterventionHealth Outcome: Waist Circumference (cm)(T3) 6 Months (cm)38.68 cmStandard Deviation 5.02
InterventionHealth Outcome: Waist Circumference (cm)(T4) 12 Months (cm)38.70 cmStandard Deviation 5.42
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T2) 3 months Physical Function45.32 score from 0-100Standard Deviation 7.84
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T3) 6 months Physical Function44.69 score from 0-100Standard Deviation 9.25
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T4) 12 months Physical Function45.71 score from 0-100Standard Deviation 7.93
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T2) 3 months53.50 score from 0-100Standard Deviation 8.03
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T3) 6 month53.12 score from 0-100Standard Deviation 9.87
ControlQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T4) 12 months50.91 score from 0-100Standard Deviation 10.69
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T3) 6 month51.30 score from 0-100Standard Deviation 8.21
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T2) 3 months Physical Function40.37 score from 0-100Standard Deviation 9.34
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T2) 3 months54.68 score from 0-100Standard Deviation 8.51
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T3) 6 months Physical Function40.91 score from 0-100Standard Deviation 9.97
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life Mental Health ( T4) 12 months51.56 score from 0-100Standard Deviation 9.93
InterventionQuality of Life: Physical (Functional) and Mental (Well-being) HealthQuality of Life (T4) 12 months Physical Function40.02 score from 0-100Standard Deviation 8.18
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlRadial Pulse (Beats Per Minute)(T3) 3 months(beats per minute)70.20 (beats per minute)Standard Deviation 12.11
ControlRadial Pulse (Beats Per Minute)(T3) 6 months(beats per minute)70.20 (beats per minute)Standard Deviation 11.11
ControlRadial Pulse (Beats Per Minute)(T4) 12 months(beats per minute)67.21 (beats per minute)Standard Deviation 8.2
InterventionRadial Pulse (Beats Per Minute)(T3) 3 months(beats per minute)69.08 (beats per minute)Standard Deviation 8.82
InterventionRadial Pulse (Beats Per Minute)(T3) 6 months(beats per minute)67.56 (beats per minute)Standard Deviation 11.3
InterventionRadial Pulse (Beats Per Minute)(T4) 12 months(beats per minute)66.82 (beats per minute)Standard Deviation 7.76
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlResting Blood Pressure(T4) 12 months Diastolic Blood Pressure (Unit of Measure: mmHg)77.38 (mmHg)Standard Deviation 10.21
ControlResting Blood Pressure(T2) 3 months Systolic Blood Pressure (Unit of Measure: mmHg)146.7 (mmHg)Standard Deviation 18.61
ControlResting Blood Pressure(T2) 3 months Diastolic Blood Pressure (Unit of Measure: mmHg)80.52 (mmHg)Standard Deviation 12.73
ControlResting Blood Pressure(T3) 6 months Systolic Blood Pressure (Unit of Measure: mmHg)142.2 (mmHg)Standard Deviation 12.76
ControlResting Blood Pressure(T3) 6 months Diastolic Blood Pressure (Unit of Measure: mmHg)77.20 (mmHg)Standard Deviation 8.94
ControlResting Blood Pressure(T4) 12 months Systolic Blood Pressure (Unit of Measure: mmHg)143.8 (mmHg)Standard Deviation 16.59
InterventionResting Blood Pressure(T3) 6 months Diastolic Blood Pressure (Unit of Measure: mmHg)78.80 (mmHg)Standard Deviation 13.1
InterventionResting Blood Pressure(T4) 12 months Diastolic Blood Pressure (Unit of Measure: mmHg)74.05 (mmHg)Standard Deviation 10.19
InterventionResting Blood Pressure(T3) 6 months Systolic Blood Pressure (Unit of Measure: mmHg)143.3 (mmHg)Standard Deviation 19.69
InterventionResting Blood Pressure(T2) 3 months Systolic Blood Pressure (Unit of Measure: mmHg)140.7 (mmHg)Standard Deviation 26.54
InterventionResting Blood Pressure(T4) 12 months Systolic Blood Pressure (Unit of Measure: mmHg)132.2 (mmHg)Standard Deviation 14.8
InterventionResting Blood Pressure(T2) 3 months Diastolic Blood Pressure (Unit of Measure: mmHg)79.52 (mmHg)Standard Deviation 14.47
Secondary

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).

ArmMeasureGroupValue (MEAN)Dispersion
ControlSix Minute Walk Test(T2) 3Months1142 FeetStandard Deviation 337.1
ControlSix Minute Walk Test(T3) 6 Months1204 FeetStandard Deviation 266.6
ControlSix Minute Walk Test(T4) 12 Months1146 FeetStandard Deviation 264.7
InterventionSix Minute Walk Test(T2) 3Months1158 FeetStandard Deviation 235.9
InterventionSix Minute Walk Test(T3) 6 Months1142 FeetStandard Deviation 295
InterventionSix Minute Walk Test(T4) 12 Months1120 FeetStandard Deviation 259.4
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
ControlWeight (Pounds)(T2) 3 months (pounds)193.1 poundsStandard Deviation 36.63
ControlWeight (Pounds)(T6) 6 months (pounds)192.6 poundsStandard Deviation 36.06
ControlWeight (Pounds)(T4) 12 months (pounds)189.0 poundsStandard Deviation 35.91
InterventionWeight (Pounds)(T2) 3 months (pounds)188.5 poundsStandard Deviation 37.11
InterventionWeight (Pounds)(T6) 6 months (pounds)186.6 poundsStandard Deviation 37.67
InterventionWeight (Pounds)(T4) 12 months (pounds)189.3 poundsStandard Deviation 37.17

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026