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Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation

Mayo Clinic logo

Mayo Clinic

Status

Withdrawn

Conditions

Cardiac Rehab
Blood Markers
Physical Activity

Treatments

Behavioral: activity monitor group
Behavioral: usual care group

Study type

Interventional

Funder types

Other

Identifiers

NCT04002388
18-009494

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Activity Monitor Group
Experimental group
Description:
This arm will receive a FitBit and will be asked to wear this for one year
Treatment:
Behavioral: activity monitor group
Usual Care Group
Active Comparator group
Description:
The usual care group will NOT receive a FitBit
Treatment:
Behavioral: usual care group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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