Seasonal activity in people with heart failure who have pacemakers or ICDs
The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
This project will see if seasonal weather changes affect how much people with heart failure who have pacemakers or defibrillators move during the year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erol Olcok Corum Training and Research Hospital Academic / other |
| Locations | 1 site (Çorum) |
| Trial ID | NCT07420088 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with heart failure who have cardiac implantable electronic devices over a full year to measure device-recorded physical activity. Activity data from the implanted devices will be linked to local weather station records to compare activity levels across seasons. Eligible participants are ambulatory adults in NYHA class I–III with ischemic or non-ischemic cardiomyopathy who live within about 50 miles of a weather reporting station; those with LVADs, major mobility-limiting conditions, recent major surgery, or cognitive impairment are excluded. Investigators will analyze seasonal patterns and the magnitude of changes in daily activity and explore associations with temperature and other weather variables.
Who should consider this trial
Good fit: Ambulatory adults over 18 with ischemic or non-ischemic cardiomyopathy, NYHA class I–III, who have a cardiac implantable electronic device and live within roughly 50 miles of a weather reporting station.
Not a fit: Patients in NYHA class IV, those using left ventricular assist devices, people with major mobility-limiting conditions, recent major surgeries, significant cognitive impairment, or who live outside the 50-mile weather station radius are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could help clinicians and patients plan activity and care by recognizing predictable seasonal dips or increases in physical activity.
How similar studies have performed: Previous research using implanted device activity and other remote-monitoring data has shown seasonal variations in activity and heart-failure events, but studies specifically linking device-recorded daily activity across full seasons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age, * Have a diagnosis of heart failure due to ischemic or non-ischemic cardiomyopathy, * Have a cardiac implantable electrical devices, * Be in New York Heart Association (NYHA) Class I-II-III. Exclusion Criteria: * Being a New York Heart Association (NYHA) Class IV resident * Not living within a 50-mile radius of a weather reporting station, * Having documented conditions that limit ambulation, including wheelchair use, serious orthopedic problems, stroke and other neurological disorders, or amputation, * Using a left ventricular assist device, * Having a history of more than five hospitalizations for any reason, * Having recently undergone major cardiovascular or orthopedic surgical procedures, including coronary artery bypass grafting, aortic aneurysm repair, joint replacement, amputation, or spinal surgery, * Having a cognitive impairment that impairs cooperation with questionnaires or tests.
Where this trial is running
Çorum
- Hitit University Erol Olcok Training and Research Hospital — Çorum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Gamze Nur Ahiskali, PT, MSc.
- Email: gmzahiskali@gmail.com
- Phone: +905514128687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.