Clinical trial NCT04002388: Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
Official title: Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiac Rehab
Physical Activity
Blood Markers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity measured by Fitbit (steps)
timeFrame: 1 year
measure: Amount of time spent sedentary based on activity counts
timeFrame: 1 year
measure: Change in plasma ceramides
timeFrame: 1 year
Secondary outcomes:
measure: Microbiome changes following an exercise program - Cardiac Rehab
timeFrame: 15 months
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amanda R Bonikowske
role: PRINCIPAL_INVESTIGATOR
References: