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Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002388
Recruitment Status : Enrolling by invitation
First Posted : June 28, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda R. Bonikowske, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cardiac Rehab Physical Activity Blood Markers Behavioral: activity monitor group Behavioral: usual care group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Amount of time spent sedentary based on activity counts [ Time Frame: 1 year ]
    Objective measure of sedentary time using an accelerometer (activity count levels)

  3. Change in plasma ceramides [ Time Frame: 1 year ]
    Examine the effect of cardiac rehabilitation on plasma ceramide levels


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Amanda R Bonikowske Mayo Clinic

Additional Information:
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Responsible Party: Amanda R. Bonikowske, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04002388     History of Changes
Other Study ID Numbers: 18-009494
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No