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RecruitingNCT07420088CIEDUpdated May 8, 2026

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

An observational study in Heart Failure, Cardiac Implantable Electrical Devices and Physical Activities, sponsored by Erol Olcok Corum Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Erol Olcok Corum Training and Research Hospital · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure
  • Cardiac Implantable Electrical Devices
  • Physical Activities

Keywords

  • Cardiac implantable electronic device
  • physical activity
  • seasonal variation
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 24 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Erol Olcok Corum Training and Research Hospital is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with heart failure with cardiac implantable electrical devices

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • Patients with Heart Failure with Cardiac Implantable Electronic Devices

    Other: follow-up study

Interventions

  • Otherfollow-up study

    Seasonal variations in physical activity will be objectively investigated in heart failure patients with implantable cardiac electronic devices.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

  2. 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.

    Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

Secondary outcomes

  1. Participant's functional capacity

    The maximal symptom-limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing functional capacity, will be used.

    Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

  2. 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.

    Time frame: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)

07

Study locations

1 of 1 sites recruiting
  • Hitit University Erol Olcok Training and Research Hospital
    Çorum, Turkey (Türkiye)
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07420088
Lead sponsor
Erol Olcok Corum Training and Research Hospital
Responsible party
Gamze Nur AHISKALI (PT, MSc. Gamze Nur Ahiskali, Erol Olcok Corum Training and Research Hospital) — Principal investigator
First posted
Feb 19, 2026
Start date
Jan 21, 2026
Primary completion
Jan 21, 2027 (estimated)
Completion
Jan 21, 2027 (estimated)
Last update
May 8, 2026

Study contacts

Gamze Nur Ahiskali, PT, MSc.
Contact
gmzahiskali@gmail.com
+905514128687

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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