Heart FailureCIEDNCT07420088
Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
An observational study of Heart Failure and Cardiac Implantable Electrical Devices, run by Erol Olcok Corum Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Implantable Electrical Devices, Physical Activities
- What is being tested?
- follow-up study
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2026to 21 Jan 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure with cardiac implantable electrical devices
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hitit University Erol Olcok Training and Research Hospital
Çorum
Gamze Nur AHISKALI, 905514128687, gmzahiskali@gmail.com
About this study
Official title: 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.
- Being tested
- follow-up study
- Keywords
- Cardiac implantable electronic device, physical activity, seasonal variation
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up studyOther
Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Heart Failure with Cardiac Implantable Electronic Devices | Not described Receives: Other: follow-up study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's objective physical activity level
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.
Measured: 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
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.
Measured: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)
Secondary outcomes (2)
Participant's functional capacity
The maximal symptom-limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing functional capacity, will be used.
Measured: 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
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.
Measured: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start21 Jan 2026
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Erol Olcok Corum Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420088
- Sponsor's protocol ID
- 2025-23
- Other IDs
- Hitit University
- Acronym
- CIED
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34225086