Trials / Withdrawn
WithdrawnNCT04002388
Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Researchers are trying to assess exercise patterns during and after cardiac rehabilitation participation and to compare changes in blood markers and the microbiome before and after rehabilitation.
Detailed description
Study participation involves a visit to Mayo Clinic at 6 months and 1 year after you begin cardiac rehabilitation. In addition to the standard of care cardiac rehab program, which consists of 36 full sessions, you would be randomized to an activity monitor group or a usual care group. If randomized to the activity monitor group you will receive a FitBit and will be asked to wear this during cardiac rehabilitation and for one year after you complete the program; complete 4 blood draws (at the start of rehab, at the end of rehab, 6 months after finishing rehab and 1 year after completing rehab) and complete questionnaires about your lifestyle, sleep, mood. The data from the FitBit will be sent to the study team for one year. If randomized to the usual care group you will complete 4 blood draws (at the start of rehab, at the end of rehab, 6 months after rehab, and 1 year after completing rehab); and complete questionnaires about your lifestyle, sleep, mood. If you agree to be in the study, you will be asked to wear monitors with capabilities to detect your heart rate or physical activity for up to 1 year. Data will be acquired from the monitors or remote device accounts. You will also be asked to fill out questionnaires about your current level of physical activity, dietary intake, mood, stress, motivation, and quality of life. You will have a blood draw. You will be asked to complete 2 different stool sample tests, saliva tests, and a fingerstick measure for glycosylated hemoglobin; performed at 4 time points. Information from your medical record will be recorded and used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | activity monitor group | will receive a FitBit and will be asked to wear this for one year |
| BEHAVIORAL | usual care group | will NOT receive a FitBit |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2022-03-01
- Completion
- 2022-03-01
- First posted
- 2019-06-28
- Last updated
- 2022-03-07
Source: ClinicalTrials.gov record NCT04002388. Inclusion in this directory is not an endorsement.