Cardiac RehabilitationSPARCNCT07214350
Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation
An observational study of Cardiac Rehabilitation and Heart Disease, run by Duke University at 1 site in United States.
Trial summary
The SPARC study will measure physical activity and functional fitness during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. This will help investigators learn if men and women maintain physical activity levels and functional fitness differently during and after they… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Heart Disease
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults participating in cardiac rehabilitation
Who may be able to join
- Age > 18 years
- Enrolled in cardiac rehabilitation within the last month
- Own a smartphone or tablet for mobile application download
Who cannot join
- Planned relocation during the study period out of the local area
- Planned medical procedure within the study period that may limit physical activity (i.e., joint replacement)
- End-stage kidney disease
- Impairment from stroke, injury, or other medical conditions that would prevent participation in or completion of the protocol
- Heart transplant
- Use of a left ventricular assist device
- Pregnant or intending to become pregnant during the study period
- Any other illness that, in the opinion of the study physician, would negatively impact or mitigate participation in or completion of the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Center for Living
Durham, North Carolina, 27705
Katherine A Collins-Bennett, PhD, 919-479-2368, katherine.collins-bennett@duke.edu
About this study
The SPARC study will measure physical activity and functional fitness during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. This will help investigators learn if men and women maintain physical activity levels and functional fitness differently during and after they complete cardiac rehabilitation. Participants in this study will have three in-person study visits and may complete two qualitative interviews over a 10-month study period. The greatest risks during the study include physical discomfort, falling, and/or shortness of breath during the fitness testing.
- Conditions
- Cardiac Rehabilitation, Heart Disease
- Keywords
- Physical Activity, Sex Differences
- Medical subject headings
- Heart Diseases, 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 |
|---|---|---|
| Adults participating in cardiac rehabilitation | Physical activity and functional fitness will be measured during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Step Count
Calculated as an average of daily steps achieved over the previous week at each timepoint.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (1)
Average moderate-to-vigorous physical activity minutes per week
Self-reported moderate-to-vigorous-intensity physical activity minutes per week using the Paffenbarger Physical Activity Questionnaire.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start2 Dec 2025
- Primary completionDec 2029 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Katherine A. Collins-Bennett, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214350
- Sponsor's protocol ID
- Pro00118596
- Other IDs
- 1K01HL177266-01A1
- Acronym
- SPARC
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This project will produce demographic, clinical and psychological obtained at baseline, 3-, and 9 months following participant enrollment. Data will be collected from a maximum of 186 research participants (total enrollment goal n = 150). To protect research participant identities, data will be de-identified; only de-identified data will be made available for sharing. Data collection will be performed at the Center for Living Campus - part of the Duke Molecular Physiology Institute - at the Duke University School of Medicine. In this proposed project for data relevant to the Specific Aims, the cleaned, item-level spreadsheet data will be shared openly, along with example transformations from initial raw data. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. The rationale for sharing only cleaned data is to foster ease of data reuse.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT07214350
- Acronym / sponsor ID
- SPARC / Pro00118596
- Conditions
- Cardiac Rehabilitation, Heart Disease
- Keywords
- Physical Activity, Sex Differences
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 9 Oct 2025 (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 SPARC study will measure physical activity and functional fitness during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. This will help investigators learn if men and women maintain physical activity levels and functional fitness differently during and after they complete cardiac rehabilitation. Participants in this study will have three in-person study visits and may complete two qualitative interviews over a 10-month study period. The greatest risks during the study include physical discomfort, falling, and/or shortness of breath during the fitness testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults participating in cardiac rehabilitation | – | –Physical activity and functional fitness will be measured during cardiac rehabilitation, right after completion of cardiac rehabilitation, and 6 months later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults participating in cardiac rehabilitation
Key inclusion criteria (3 listed)
- Age > 18 years
- Enrolled in cardiac rehabilitation within the last month
- Own a smartphone or tablet for mobile application download
Key exclusion criteria (8 listed)
- Planned relocation during the study period out of the local area
- Planned medical procedure within the study period that may limit physical activity (i.e., joint replacement)
- End-stage kidney disease
- Impairment from stroke, injury, or other medical conditions that would prevent participation in or completion of the protocol
- Heart transplant
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
Average Daily Step Count
Time frame: Baseline, 3 months, 9 months
Calculated as an average of daily steps achieved over the previous week at each timepoint.
1 secondary outcome
Average moderate-to-vigorous physical activity minutes per week
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: Yes. This project will produce demographic, clinical and psychological obtained at baseline, 3-, and 9 months following participant enrollment. Data will be collected from a maximum of 186 research participants (total enrollment goal n = 150). To protect research participant identities, data will be de-identified; only de-identified data will be made available for sharing. Data collection will be performed at the Center for Living Campus - part of the Duke Molecular Physiology Institute - at the Duke University School of Medicine. In this proposed project for data relevant to the Specific Aims, the cleaned, item-level spreadsheet data will be shared openly, along with example transformations from initial raw data. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. The rationale for sharing only cleaned data is to foster ease of data reuse.
Related trials for Cardiac Rehabilitation
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Recruiting
Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction
Heart Failure, Ventricular Function, Left
Recruiting
Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
Not yet recruiting
Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Recruiting
Cardiovascular Rehabilitation After Infrarenal Aortic Aneurysm Repair
Abdominal Aortic Aneurysm
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.
Katherine A. Collins-Bennett, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation and Heart Disease, run by Duke University at 1 site in United States.
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 8 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine A Collins-Bennett, PhD (919-479-2368, katherine.collins-bennett@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Daily Step Count (time frame: Baseline, 3 months, 9 months). 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 3 Dec 2025.