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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT07420088
- Acronym / sponsor ID
- CIED / 2025-23
- Keywords
- Cardiac implantable electronic device, physical activity, seasonal variation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Erol Olcok Corum Training and Research HospitalUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Heart Failure with Cardiac Implantable Electronic Devices | – | Other: follow-up study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure with cardiac implantable electrical devices
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up studySeasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices. | Other | Patients with Heart Failure with Cardiac Implantable Electronic Devices |
Primary outcome
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.
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.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 34225086Shoemaker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gamze Nur Ahiskali, PT, MSc. (+905514128687, gmzahiskali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07420088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.