Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
NCT ID: NCT04002388
Last Updated: 2022-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-01-31
2022-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Activity Monitor Group
This arm will receive a FitBit and will be asked to wear this for one year
activity monitor group
will receive a FitBit and will be asked to wear this for one year
Usual Care Group
The usual care group will NOT receive a FitBit
usual care group
will NOT receive a FitBit
Interventions
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activity monitor group
will receive a FitBit and will be asked to wear this for one year
usual care group
will NOT receive a FitBit
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Amanda R. Bonikowske
Principal Investigator
Principal Investigators
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Amanda R Bonikowske
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-009494
Identifier Type: -
Identifier Source: org_study_id
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