Blood Markers, Cardiac Rehab, Physical Activity
Conditions
Brief 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.
Interventions
BEHAVIORALactivity monitor group
will receive a FitBit and will be asked to wear this for one year
BEHAVIORALusual care group
will NOT receive a FitBit
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult 18 years and older * English speaking * Able to provide consent * Has a qualifying indication for cardiac rehabilitation (ie. Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, and stable angina), owns a smart phone and able to download the fitness monitor app (and willing to have their data downloaded from their fitness monitor after completion of cardiac rehab), and able to participate in cardiac rehabilitation.
Exclusion criteria
* Does not own a smart phone or is unwilling to download the app or is unable to participate in cardiac rehab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma ceramides | 1 year | Examine the effect of cardiac rehabilitation on plasma ceramide levels |
| Physical activity measured by Fitbit (steps) | 1 year | Objective measure of physical activity during cardiac rehabilitation participation and for one year after using a Fitbit and Fitabase. |
| Amount of time spent sedentary based on activity counts | 1 year | Objective measure of sedentary time using an accelerometer (activity count levels) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome changes following an exercise program - Cardiac Rehab | 15 months | Examine changes in the microbiome and transcriptome following participation in cardiac based on stool, saliva, and biological markers |
Outcome results
None listed