Trial Outcomes & Findings for Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS) (NCT NCT04135859)
NCT ID: NCT04135859
Last Updated: 2024-09-19
Results Overview
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
From baseline to follow-up (approximately 22 weeks).
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Fitbit Only
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Fitbit Only
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Withdrawal due to screening failure
|
1
|
2
|
|
Overall Study
Did not complete stress test
|
3
|
3
|
|
Overall Study
Did not wear accelerometer and did not complete stress test
|
0
|
2
|
Baseline Characteristics
Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)
Baseline characteristics by cohort
| Measure |
Fitbit Only
n=18 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=15 Participants
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sedentary Behavior
|
561.2 Average min/day
STANDARD_DEVIATION 100.0 • n=5 Participants
|
580.3 Average min/day
STANDARD_DEVIATION 118.7 • n=7 Participants
|
570.2 Average min/day
STANDARD_DEVIATION 107.8 • n=5 Participants
|
|
VO2Peak
|
30.3 mL/kg/min
STANDARD_DEVIATION 7.1 • n=5 Participants
|
31.4 mL/kg/min
STANDARD_DEVIATION 8.6 • n=7 Participants
|
30.9 mL/kg/min
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Age, Continuous
|
22.2 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
22.3 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
22.2 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
15 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
MVPA
|
7.5 Average min/day
STANDARD_DEVIATION 4.8 • n=5 Participants
|
9.4 Average min/day
STANDARD_DEVIATION 5.0 • n=7 Participants
|
8.4 Average min/day
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Population: Two participants in the Fitbit + Coaching group had missing MVPA data
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
Outcome measures
| Measure |
Fitbit Only
n=17 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=13 Participants
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Moderate to Vigorous Physical Activity (MVPA)
|
-0.7 Average change in minutes per day
Standard Deviation 6.6
|
8.8 Average change in minutes per day
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Population: Three participants in the Fitbit + Coaching group had missing data for sedentary behavior
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
Outcome measures
| Measure |
Fitbit Only
n=17 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=12 Participants
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Sedentary Behavior
|
13.6 Average change in minutes per day
Standard Deviation 88.7
|
-49.8 Average change in minutes per day
Standard Deviation 92.3
|
SECONDARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Population: Three participants from the Fitbit Only group and four participants from the Fitbit + Coaching Sessions group had missing data for VO2peak.
Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.
Outcome measures
| Measure |
Fitbit Only
n=14 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=9 Participants
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Exercise Tolerance
|
0.41 Average change in mL/kg/min
Standard Deviation 2.33
|
-0.32 Average change in mL/kg/min
Standard Deviation 1.68
|
Adverse Events
Fitbit Only
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Fitbit + Coaching Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fitbit Only
n=19 participants at risk
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=17 participants at risk
In the Fitbit + Coaching Sessions arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
5.3%
1/19 • Number of events 1 • Randomization to follow-up (approximately 22 weeks)
An adverse event is an unanticipated change in cardiovascular, musculoskeletal, or emotional symptoms that are (1) concerning to the participant and (2) results in seeking medical attention, if cardiovascular or musculoskeletal in nature. Any condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event.
|
0.00%
0/17 • Randomization to follow-up (approximately 22 weeks)
An adverse event is an unanticipated change in cardiovascular, musculoskeletal, or emotional symptoms that are (1) concerning to the participant and (2) results in seeking medical attention, if cardiovascular or musculoskeletal in nature. Any condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place