Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study was withdrawn due to impracticalities in logistics during the COVID-19 pandemic.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Monitor Group | Experimental | This arm will receive a FitBit and will be asked to wear this for one year |
|
| Usual Care Group | Active Comparator | The usual care group will NOT receive a FitBit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activity monitor group | Behavioral | will receive a FitBit and will be asked to wear this for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity measured by Fitbit (steps) | Objective measure of physical activity during cardiac rehabilitation participation and for one year after using a Fitbit and Fitabase. | 1 year |
| Amount of time spent sedentary based on activity counts | Objective measure of sedentary time using an accelerometer (activity count levels) | 1 year |
| Change in plasma ceramides | Examine the effect of cardiac rehabilitation on plasma ceramide levels | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome changes following an exercise program - Cardiac Rehab | Examine changes in the microbiome and transcriptome following participation in cardiac based on stool, saliva, and biological markers | 15 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amanda R Bonikowske | Mayo Clinic | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| usual care group | Behavioral | will NOT receive a FitBit |
|