Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation
SPARC
2 other identifiers
observational
150
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2025
Longer than P75 for all trials
1 active site
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
October 7, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
December 3, 2025
December 1, 2025
4 years
October 7, 2025
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average Daily Step Count
Calculated as an average of daily steps achieved over the previous week at each timepoint.
Baseline, 3 months, 9 months
Secondary Outcomes (1)
Average moderate-to-vigorous physical activity minutes per week
9 months
Study Arms (1)
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.
Eligibility Criteria
Adults participating in cardiac rehabilitation
You may qualify if:
- Age \> 18 years
- Enrolled in cardiac rehabilitation within the last month
- Own a smartphone or tablet for mobile application download
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Duke Center for Living
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine A. Collins-Bennett, PhD
Duke University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2025
First Posted
October 9, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
August 1, 2030
Last Updated
December 3, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be shared either at the time of publication or at the end of the performance period, whichever comes first.
- Access Criteria
- The Duke Library DRD provides searchable study-level metadata for dataset discovery, assigns DOIs as persistent identifiers, and has a robust preservation plan to ensure long-term access. Data will be discoverable online through a standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The RDR will assign appropriate metadata (Dublin Core) for discoverability and provide a DataCite Digital Object Identifier (DOI) for persistent access and unique identification of the data, all data in the RDR are findable with standard indexing tools and included in Google Datasets and DataCite Commons.
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.