Cardiac Rehabilitation
Conditions
Brief summary
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.
Detailed description
Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.
Interventions
BEHAVIORALActivity Tracker
Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.
Sponsors
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a pilot study. All participants receive the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* coronary heart disease * currently attending cardiac rehabilitation with at least 4 weeks left * \>=18 years of age * own a smart phone and able to participate in mobile health program * able to understand and write English * adequate clinical stability * understand and sign informed consent
Exclusion criteria
* currently using a digital physical activity tracker * past use of a digital activity tracker * planning to relocate in 12 weeks * acute coronary artery disease symptoms * decompensated heart failure * New York Heart Association class IV heart failure * severe valvular heart disease * severe pulmonary hypertension * cardiac transplantation * visually impaired, severe * end stage renal disease * impairment from stroke, injury, or other medical disorder that precludes participation * dementia that precludes ability to participate and follow protocol * inability or unwillingness to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Steps Per Day (Preintervention Period) | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks | Average steps per day measured by the activity tracker |
| Average Physical Activity in Minutes Per Day (Preintervention Period) | pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks | Average very active minutes per day of physical activity measured by the activity tracker |
| Average Steps Per Day (Intervention Period) | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks | Average steps per day measured by the activity tracker |
| Average Physical Activity in Minutes Per Day (Intervention Period) | Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks | Average very active minutes per day of physical activity measured by the activity tracker |
| Average Steps Per Day (Maintenance Period) | Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks | Average steps per day measured by the activity tracker |
| Average Physical Activity Per Day (Maintenance Period) | Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks | Average very active minutes per day of physical activity measured by the activity tracker |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Activity Tracker Participants provided an activity tracker to wear and weekly reports
Activity Tracker: Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Activity Tracker | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Age, Continuous | 61.8 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 5 Participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Average Physical Activity in Minutes Per Day (Intervention Period)
Average very active minutes per day of physical activity measured by the activity tracker
Time frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Physical Activity in Minutes Per Day (Intervention Period) | 11 minutes per day |
Primary
Average Physical Activity in Minutes Per Day (Preintervention Period)
Average very active minutes per day of physical activity measured by the activity tracker
Time frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Physical Activity in Minutes Per Day (Preintervention Period) | 14 minutes per day |
Primary
Average Physical Activity Per Day (Maintenance Period)
Average very active minutes per day of physical activity measured by the activity tracker
Time frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Physical Activity Per Day (Maintenance Period) | 7 minutes per day |
Primary
Average Steps Per Day (Intervention Period)
Average steps per day measured by the activity tracker
Time frame: Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Steps Per Day (Intervention Period) | 5960 steps per day |
Primary
Average Steps Per Day (Maintenance Period)
Average steps per day measured by the activity tracker
Time frame: Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Steps Per Day (Maintenance Period) | 5158 steps per day |
Primary
Average Steps Per Day (Preintervention Period)
Average steps per day measured by the activity tracker
Time frame: pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks
Population: One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activity Tracker | Average Steps Per Day (Preintervention Period) | 6507 steps per day |