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Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Rehab Physical Activity Blood Markers | Behavioral: activity monitor group Behavioral: usual care group | Not Applicable |
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 : | 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 : | September 2021 |
| Estimated Primary Completion Date : | March 2022 |
| Estimated Study Completion Date : | March 2022 |
| 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
|
- 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
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| United States, Minnesota | |
| Mayo Clinic in Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | 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 | April 26, 2021 | ||||
| Estimated Study Start Date ICMJE | September 2021 | ||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE |
75 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | March 2022 | ||||
| Estimated Primary Completion Date | March 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| 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 |
|
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Amanda R. Bonikowske, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Mayo Clinic | ||||
| Verification Date | April 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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