Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
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|ClinicalTrials.gov Identifier: NCT04002388|
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2019
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Rehab Physical Activity Blood Markers||Behavioral: activity monitor group Behavioral: usual care group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Activity Monitor Group
This arm will receive a FitBit and will be asked to wear this for one year
Behavioral: activity monitor group
will receive a FitBit and will be asked to wear this for one year
Active Comparator: Usual Care Group
The usual care group will NOT receive a FitBit
Behavioral: usual care group
will NOT receive a FitBit
- Physical activity measured by Fitbit (steps) [ Time Frame: 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 [ Time Frame: 1 year ]Objective measure of sedentary time using an accelerometer (activity count levels)
- Change in plasma ceramides [ Time Frame: 1 year ]Examine the effect of cardiac rehabilitation on plasma ceramide levels
- Microbiome changes following an exercise program - Cardiac Rehab [ Time Frame: 15 months ]Examine changes in the microbiome and transcriptome following participation in cardiac based on stool, saliva, and biological markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002388
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Amanda R Bonikowske||Mayo Clinic|