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Clinical Trials/NCT07592494
NCT07592494RecruitingNot Applicable

Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

Erol Olcok Corum Training and Research Hospital1 site in 1 country36 target enrollmentStarted: May 11, 2026Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
36
Locations
1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.
  2. To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.
  3. To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
  • •At least 3 months have passed since device implantation and there have been no complications at the last device control
  • •Being in New York Heart Association (NYHA) Class II-III
  • •Patients without cooperation problems
  • •Patients who volunteer to participate in the study

Exclusion Criteria

  • •Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,
  • •Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,
  • •Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),
  • •Patients with a history of shoulder surgery (patients with limitations in range of motion),
  • •Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,
  • •Patients with decompensated heart failure,
  • •Patients with a history of ICD-incompatible shock,
  • •Patients with a history of unstable angina pectoris, acute myocardial infarction, or cardiac surgery within the last 3 months,
  • •Patients who have experienced acute atrial fibrillation, ventricular tachycardia, and ventricular fibrillation within the last 3 months,
  • •Patients with actively treated malignancy or collagen tissue disease receiving systemic steroids
  • •Patients with chronic kidney disease undergoing dialysis where volume load is unstable,
  • •Persistent ventricular arrhythmias during baseline cardiopulmonary exercise testing.

Arms & Interventions

Control Group

Active Comparator

Intervention: Lower Extremity Aerobic Exercise Training (Other)

High-Intensity Interval Group

Experimental

Intervention: High-Intensity Interval Upper Extremity Aerobic Exercise Training (Other)

High-Intensity Interval Group

Experimental

Intervention: Lower Extremity Aerobic Exercise Training (Other)

Moderate Intensity Continuous Group

Experimental

Intervention: Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training (Other)

Moderate Intensity Continuous Group

Experimental

Intervention: Lower Extremity Aerobic Exercise Training (Other)

Investigators

Sponsor
Erol Olcok Corum Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gamze Nur AHISKALI

physiotherapist

Erol Olcok Corum Training and Research Hospital

Study Sites (1)

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