Cardiovascular Disease Other, Physical Activity
Conditions
Keywords
congenital heart disease, physical activity
Brief summary
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALPhysical Activity Monitoring
A physical activity monitor (Fitbit) will be provided to both groups.
Sponsors
Jamie Jackson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Investigator, research assistants, coaches (interventionists), and participants do not know which condition a participant is in until the condition is revealed (opening an envelope with the condition listed) after the participant consents to Phase 2. Envelopes with the conditions were prepared by the study statistician.
Intervention model description
Study includes 2 possible conditions to which participants are randomized: (1) Fitbit only and (2) Fitbit + coaching sessions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Between the ages of 18-25 (if 18, must no longer be in high school and no longer living at home) 2. Are diagnosed with moderate or complex structural congenital heart disease 3. Live within 120 miles of Nationwide Children's Hospital
Exclusion criteria
1. Do no speak or write proficiently in English 2. Have cognitive impairments that would interfere with the completion of study procedures 3. Are diagnosed with a genetic syndrome (e.g., Downs, Marfans) 4. Have been engaged in a formal exercise program within the past 6 months 5. Underwent open-heart surgery or have had a transcatheter valve replacement in the last 3 months 6. Are otherwise prohibited by their cardiologist to engage in at least moderate levels of physical activity 7. Are unable to complete a treadmill-based exercise stress test 8. Are currently pregnant 9. Have contraindications for exercise based on an exercise stress test (e.g., exercise-induced arrhythmias or evidence of cardiac ischemia) 10. \>150 min/weekday of moderate-to-vigorous physical activity per the accelerometer 11. Do not have access or a device for videoconferencing with the coach
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate to Vigorous Physical Activity (MVPA) | From baseline to follow-up (approximately 22 weeks). | Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary Behavior | From baseline to follow-up (approximately 22 weeks). | Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer. |
| Exercise Tolerance | From baseline to follow-up (approximately 22 weeks). | Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 15 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete stress test | 3 | 3 |
| Overall Study | Did not wear accelerometer and did not complete stress test | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
| Overall Study | Withdrawal due to screening failure | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Fitbit Only | Fitbit + Coaching Sessions |
|---|---|---|---|
| Age, Continuous | 22.2 years STANDARD_DEVIATION 2.1 | 22.2 years STANDARD_DEVIATION 1.9 | 22.3 years STANDARD_DEVIATION 2.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 18 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| MVPA | 8.4 Average min/day STANDARD_DEVIATION 4.9 | 7.5 Average min/day STANDARD_DEVIATION 4.8 | 9.4 Average min/day STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 31 Participants | 16 Participants | 15 Participants |
| Region of Enrollment United States | 33 participants | 18 participants | 15 participants |
| Sedentary Behavior | 570.2 Average min/day STANDARD_DEVIATION 107.8 | 561.2 Average min/day STANDARD_DEVIATION 100 | 580.3 Average min/day STANDARD_DEVIATION 118.7 |
| Sex: Female, Male Female | 19 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 6 Participants |
| VO2Peak | 30.9 mL/kg/min STANDARD_DEVIATION 7.7 | 30.3 mL/kg/min STANDARD_DEVIATION 7.1 | 31.4 mL/kg/min STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 1 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
Primary
Moderate to Vigorous Physical Activity (MVPA)
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
Time frame: From baseline to follow-up (approximately 22 weeks).
Population: Two participants in the Fitbit + Coaching group had missing MVPA data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Only | Moderate to Vigorous Physical Activity (MVPA) | -0.7 Average change in minutes per day | Standard Deviation 6.6 |
| Fitbit + Coaching Sessions | Moderate to Vigorous Physical Activity (MVPA) | 8.8 Average change in minutes per day | Standard Deviation 15.7 |
p-value: 0.023Mixed Models Analysis
Secondary
Exercise Tolerance
Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Only | Exercise Tolerance | 0.41 Average change in mL/kg/min | Standard Deviation 2.33 |
| Fitbit + Coaching Sessions | Exercise Tolerance | -0.32 Average change in mL/kg/min | Standard Deviation 1.68 |
p-value: 0.43Mixed Models Analysis
Secondary
Sedentary Behavior
Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
Time frame: From baseline to follow-up (approximately 22 weeks).
Population: Three participants in the Fitbit + Coaching group had missing data for sedentary behavior
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Only | Sedentary Behavior | 13.6 Average change in minutes per day | Standard Deviation 88.7 |
| Fitbit + Coaching Sessions | Sedentary Behavior | -49.8 Average change in minutes per day | Standard Deviation 92.3 |
p-value: 0.06Mixed Models Analysis