Study Stopped
The study was withdrawn due to impracticalities in logistics during the COVID-19 pandemic.
Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2019
CompletedFirst Posted
Study publicly available on registry
June 28, 2019
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMarch 7, 2022
February 1, 2022
2 months
June 26, 2019
February 18, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Amount of time spent sedentary based on activity counts
Objective measure of sedentary time using an accelerometer (activity count levels)
1 year
Change in plasma ceramides
Examine the effect of cardiac rehabilitation on plasma ceramide levels
1 year
Secondary Outcomes (1)
Microbiome changes following an exercise program - Cardiac Rehab
15 months
Study Arms (2)
Activity Monitor Group
EXPERIMENTALThis arm will receive a FitBit and will be asked to wear this for one year
Usual Care Group
ACTIVE COMPARATORThe usual care group will NOT receive a FitBit
Interventions
will receive a FitBit and will be asked to wear this for one year
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Does not own a smart phone or is unwilling to download the app or is unable to participate in cardiac rehab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amanda R Bonikowske
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 26, 2019
First Posted
June 28, 2019
Study Start
January 1, 2022
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
March 7, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share