Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
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
- The protocol lists: follow-up study.
- Who it may be relevant to
- Registry conditions: Heart Failure, Cardiac Implantable Electrical Devices, Physical Activities. 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
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
Overview
The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices. Patients with heart failure who have a cardiac implantable electronic device will be evaluated throughout the year.
Interventions
- Other follow-up study
Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.
Primary outcome measures
- Participant's objective physical activity level [Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)]
- Participant's subjective physical activity level [Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)]
Secondary outcome measures (2)
- Participant's functional capacity [Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)]
- Participant's motivation for physical activity [Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)]
Eligibility 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.
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
Turkey (Türkiye) · 1 center
- Hitit University Erol Olcok Training and Research Hospital — Çorum
Publications
- Shoemaker MJ, Kampfschulte A, Rustmann S, Dickinson MG. Dynamic factor analysis of seasonal variation in daily physical activity in individuals with heart failure and implanted cardiac devices. Heart Lung. 2021 Nov-Dec;50(6):754-762. doi: 10.1016/j.hrtlng.2021.06.001. Epub 2021 Jul 2. PMID 34225086
Identifiers
NCT: NCT07420088 · 2025-23 · Hitit University