Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices (CIED)

May 5, 2026 updated by: Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital

The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Çorum, Turkey (Türkiye)
        • Recruiting
        • Hitit University Erol Olcok Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with heart failure with cardiac implantable electrical devices

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Heart Failure with Cardiac Implantable Electronic Devices
Other: follow-up study
Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Objective measurement of physical activity will be assessed using an accelerometer (Garmin Vivosmart 5). The accelerometer will be placed on the patient's non-dominant wrist for one week, 5 days a week during weekdays and 2 days a week on weekends. The accelerometer can be used day and night, while sleeping or showering, and has enough battery life to collect activity data throughout the day.
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)
Additionally, physical activity will be assessed using International Pyhsical Activity Questionnaire Short Form (IPAQ). The questionnaire examines physical activity in four different groups: vigorous physical activity, moderate physical activity, walking, and sitting. In the results evaluation, the data is converted to metabolic rate (MET) values and calculated accordingly.
Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The maximal symptom-limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing functional capacity, will be used.
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)
This 16-item scale includes individual, environmental, and irrational dimensions that influence participation motivation. The total score changes between 16 and 80. Higher scores indicate higher motivation for participating in physical activity.
Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erol Olcok Corum Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Shoemaker MJ, Kampfschulte A, Rustmann S, Dickinson MG. 2021. '' Dynamic factor analysis of seasonal variation in daily physical activity in individuals with heart failure and implanted cardiac devices'', Heart and Lung, 50(6), 754-62.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

January 21, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-23
  • Hitit University (Other Identifier: Hitit University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on follow-up study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe