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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 25, 2020
Sponsor:
Information provided by (Responsible Party):
Amanda R. Bonikowske, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date November 25, 2020
Estimated Study Start Date  ICMJE November 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2019)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
Official Title  ICMJE Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Cardiac Rehab
  • Physical Activity
  • Blood Markers
Intervention  ICMJE
  • Behavioral: activity monitor group
    will receive a FitBit and will be asked to wear this for one year
  • Behavioral: usual care group
    will NOT receive a FitBit
Study Arms  ICMJE
  • Experimental: Activity Monitor Group
    This arm will receive a FitBit and will be asked to wear this for one year
    Intervention: Behavioral: activity monitor group
  • Active Comparator: Usual Care Group
    The usual care group will NOT receive a FitBit
    Intervention: Behavioral: usual care group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002388
Other Study ID Numbers  ICMJE 18-009494
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amanda R. Bonikowske, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amanda R Bonikowske Mayo Clinic
PRS Account Mayo Clinic
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP