Menu
Recruiting NCT07592494

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

No phase Interventional Heart Failure Implantable Cardioverter Defibrillator (ICD) Cardiac Resynchronization Therapy Devices

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Intensity Interval Upper Extremity Aerobic Exercise Training, Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training, Lower Extremity Aerobic Exercise Training.
Who it may be relevant to
Registry conditions: Heart Failure, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy Devices. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other High-Intensity Interval Upper Extremity Aerobic Exercise Training
    total of 20 minutes, consisting of 5 minutes of warm-up, 3x2 minutes of high-intensity training at 80-90% of maximum workload, 2x2 minutes of active rest at 30-40% of maximum workload, and 5 minutes of cool-down
  • Other Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training
    a total of 20 minutes, consisting of 5 minutes of warm-up, 10 minutes at 70-80% of maximum workload, and 5 minutes of cool-down
  • Other Lower Extremity Aerobic Exercise Training
    a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption

Primary outcome measures

  • Maximal arm exercise capacity [Time frame: baseline and 8 weeks]
  • Functional arm exercise capacity [Time frame: baseline and 8 weeks]
  • Cardiorespiratory Fitness [Time frame: baseline and 8 weeks]
Secondary outcome measures (4)
  • Peripheral muscle strength [Time frame: baseline and 8 weeks]
  • Activities of Daily Living [Time frame: baseline and 8 weeks]
  • Health-related quality of life [Time frame: baseline and 8 weeks]
  • Disease-related quality of life [Time frame: baseline and 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit — Çorum

Identifiers

NCT: NCT07592494 · 2026-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗