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Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)
NA trial testing Physical Activity Lifestyle Intervention in Cardiovascular Disease Other in 36 participants. Completed in 9 February 2022.
| Lead sponsor | Jamie Jackson |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 36 |
| Start date | 14 March 2019 |
| Primary completion | 9 February 2022 |
| Estimated completion | 9 February 2022 |
| Sites | 1 location across United States |
Jamie Jackson
Adults 18 to 25, any sex, with Cardiovascular Disease Other or Physical Activity. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
| Group | Value | 95% CI |
|---|---|---|
| Fitbit Only | -0.7 | ± 6.6 |
| Fitbit + Coaching Sessions | 8.8 | ± 15.7 |
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
| Group | Value | 95% CI |
|---|---|---|
| Fitbit Only | 13.6 | ± 88.7 |
| Fitbit + Coaching Sessions | -49.8 | ± 92.3 |
Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.
| Group | Value | 95% CI |
|---|---|---|
| Fitbit Only | 0.41 | ± 2.33 |
| Fitbit + Coaching Sessions | -0.32 | ± 1.68 |
Time frame: Randomization to follow-up (approximately 22 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|---|
| Ankle sprain | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT04135859 adverse events section.
This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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