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Recruiting NCT07214350

Sex Differences in Barriers and Participation in Physical Activity During and Following Cardiac Rehabilitation

Observational Cardiac Rehabilitation Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiac Rehabilitation, Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Average Daily Step Count [Time frame: Baseline, 3 months, 9 months]
Secondary outcome measures (1)
  • Average moderate-to-vigorous physical activity minutes per week [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Enrolled in cardiac rehabilitation within the last month
  • Own a smartphone or tablet for mobile application download

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Duke Center for Living — Durham

Identifiers

NCT: NCT07214350 · Pro00118596 · 1K01HL177266-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗