Cardiac DiseaseNCT04481490
A Study to Objectively Measure Physical Activity and Sedentary Behavior During Cardiac Rehabilitation
An observational study of Cardiac Disease and Myocardial Infarction, run by Mayo Clinic.
Trial summary
The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Myocardial Infarction, Cardiac Valve Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2023
- Phase
- Observational
- 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
Study population: Patients with qualifying indication for cardiac rehabilitation (e.g. acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, stable angina, heart failure).
Who may be able to join
- Adult 18 years and older.
- Able to provide consent.
- Has a qualifying indication for cardiac rehabilitation and able to participate in cardiac rehabilitation.
Who cannot join
- Unwilling or unable to participate in cardiac rehabilitation.
About this study
Official title: Objective Measure of Physical Activity and Sedentary Behavior During Cardiac Rehabilitation: Are Patients Achieving Recommendations/Guidelines
The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation.
Read the detailed description
Participants enrolled in either home-based or center-based cardiac rehabilitation will be instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and 12-weeks, to objectively measure their physical activity level during the cardiac rehabilitation program. A questionnaire will also be completed by the participant at baseline and 12-weeks to subjectively measure their physical activity level, based on self-report activities over the previous 7-days.
Enrollment in home-based versus center-based cardiac rehabilitation will be based on the availability of cardiac rehabilitation facilities and/or patient preference. There is no random allocation or assignment to groups by the study team.
- Keywords
- cardiac rehabilitation, physical activity, accelerometry, home-based
- Medical subject headings
- Heart Diseases, Myocardial Infarction, Heart Valve Diseases, Coronary Artery Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Home-based | Cardiac rehabilitation (including exercise training) delivered in a home-based setting, facilitated remotely by Mayo Clinic staff. | |
| Center-based | Cardiac rehabilitation (including exercise training) delivered in a center-based setting, facilitated in person by Mayo Clinic staff. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry
Change in minutes at a moderate-vigorous activity intensity are objectively measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends in moderate-vigorous activities per day, and will be worn by the participant for 7-days. A higher number of minutes per day indicates a greater physical activity level.
Measured: Baseline, 4-weeks, 8-weeks, and 12-weeks
Secondary outcomes (2)
Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire
Change in minutes at a moderate-vigorous activity intensity are subjectively measured (self-reported) using the International Physical Activity Questionnaire (IPAQ). The IPAQ captures the number of minutes a participant spends in moderate-vigorous activities per day, based on participant's reporting of the previous 7-days. A higher number of minutes per day indicates a greater physical activity level.
Measured: Baseline, 12-weeks
Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.
Change in minutes spent in inactive (sedentary) behavior, measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends inactive per day, and will be worn by the participant for 7-days. A higher number of minutes per day of inactive time indicates increased sedentary behavior.
Measured: Baseline, 4-weeks, 8-weeks, and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study startJan 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Stopped due to lack of personnel and funding support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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 Bonikowske, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481490
- Sponsor's protocol ID
- 20-005866
- Status last verified
- Feb 2022
- First submitted
- 20 Jul 2020
- Last updated
- 11 Feb 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 11 Feb 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
- NCT04481490
- Acronym / sponsor ID
- 20-005866
- Keywords
- cardiac rehabilitation, physical activity, accelerometry, home-based
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Stopped due to lack of personnel and funding support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 22 Jul 2020 (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.
The purpose of this study is to assess exercise patterns during home-based or center-based cardiac rehabilitation participation.
Detailed description
Participants enrolled in either home-based or center-based cardiac rehabilitation will be instructed to wear an accelerometer device for 7-days at baseline, 4-weeks, 8-weeks, and 12-weeks, to objectively measure their physical activity level during the cardiac rehabilitation program. A questionnaire will also be completed by the participant at baseline and 12-weeks to subjectively measure their physical activity level, based on self-report activities over the previous 7-days.
Enrollment in home-based versus center-based cardiac rehabilitation will be based on the availability of cardiac rehabilitation facilities and/or patient preference. There is no random allocation or assignment to groups by the study team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based | – | –Cardiac rehabilitation (including exercise training) delivered in a home-based setting, facilitated remotely by Mayo Clinic staff. |
| Center-based | – | –Cardiac rehabilitation (including exercise training) delivered in a center-based setting, facilitated in person by Mayo Clinic staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with qualifying indication for cardiac rehabilitation (e.g. acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, stable angina, heart failure).
Key inclusion criteria (3 listed)
- Adult 18 years and older.
- Able to provide consent.
- Has a qualifying indication for cardiac rehabilitation and able to participate in cardiac rehabilitation.
Key exclusion criteria (1 listed)
- Unwilling or unable to participate in cardiac rehabilitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry
Time frame: Baseline, 4-weeks, 8-weeks, and 12-weeks
Change in minutes at a moderate-vigorous activity intensity are objectively measured by an accelerometer device that senses movement. The device captures the number of minutes a participant spends in moderate-vigorous activities per day, and will be worn by the participant for 7-days. A higher number of minutes per day indicates a greater physical activity level.
2 secondary outcomes
Change in minutes spent in moderate-vigorous physical activity, measured by questionnaire
Time frame: Baseline, 12-weeks
Change in minutes spent in inactive (sedentary) behavior, measured by accelerometry.
Time frame: Baseline, 4-weeks, 8-weeks, and 12-weeks
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 11 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Bonikowske, PhD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Myocardial Infarction, 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 3 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 11 Feb 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?
Change in minutes spent in moderate-vigorous physical activity, measured by accelerometry (time frame: Baseline, 4-weeks, 8-weeks, and 12-weeks). 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 11 Feb 2022.