Cardiac RehabNCT04002388
Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
A study testing activity monitor group in people with Cardiac Rehab and Physical Activity, run by Mayo Clinic.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehab, Physical Activity, Blood Markers
- What is being tested?
- activity monitor group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Does not own a smart phone or is unwilling to download the app or is unable to participate in cardiac rehab.
About this study
Official title: Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
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.
Read the 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.
- Conditions
- Cardiac Rehab, Physical Activity, Blood Markers
- Being tested
- activity monitor group, usual care group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity monitor groupBehavioural
will receive a FitBit and will be asked to wear this for one year
usual care groupBehavioural
will NOT receive a FitBit
| Study group | Role | What they receive |
|---|---|---|
| Activity Monitor Group | Experimental | This arm will receive a FitBit and will be asked to wear this for one year Receives: Behavioral: activity monitor group |
| Usual Care Group | Active comparator | The usual care group will NOT receive a FitBit Receives: Behavioral: usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Amount of time spent sedentary based on activity counts
Objective measure of sedentary time using an accelerometer (activity count levels)
Measured: 1 year
Change in plasma ceramides
Examine the effect of cardiac rehabilitation on plasma ceramide levels
Measured: 1 year
Secondary outcomes (1)
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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study startJan 2022 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: The study was withdrawn due to impracticalities in logistics during the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda R. Bonikowske, Mayo Clinic
- Investigators
- Amanda R Bonikowske, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002388
- Sponsor's protocol ID
- 18-009494
- Status last verified
- Feb 2022
- First submitted
- 26 Jun 2019
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
- ClinicalTrials.gov ID
- NCT04002388
- Acronym / sponsor ID
- 18-009494
- Conditions
- Cardiac Rehab, Physical Activity, Blood Markers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to impracticalities in logistics during the COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Monitor Group | Experimental | Behavioral: activity monitor groupThis arm will receive a FitBit and will be asked to wear this for one year |
| Usual Care Group | Active comparator | Behavioral: usual care groupThe usual care group will NOT receive a FitBit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Does not own a smart phone or is unwilling to download the app or is unable to participate in cardiac rehab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activity monitor groupwill receive a FitBit and will be asked to wear this for one year | Behavioural | Activity Monitor Group |
| usual care groupwill NOT receive a FitBit | Behavioural | Usual Care Group |
Primary outcome
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
1 secondary outcome
Microbiome changes following an exercise program - Cardiac Rehab
Time frame: 15 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda R Bonikowske principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing activity monitor group in people with Cardiac Rehab and Physical Activity, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity measured by Fitbit (steps) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.