Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation

Physical Activity Clinical Trial

Official title:

Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04002388
• Other study ID #: 18-009494
• Status: Withdrawn
• Phase: N/A
• Start date: January 2022
• Est. completion date: March 2022

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Markers
• Cardiac Rehab
• Physical Activity

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Amount of time spent sedentary based on activity counts	Objective measure of sedentary time using an accelerometer (activity count levels)	1 year
Primary	Change in plasma ceramides	Examine the effect of cardiac rehabilitation on plasma ceramide levels	1 year
Secondary	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

External Links

•   Mayo Clinic Clinical Trials