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 Hospital36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure Implantable Cardioverter Defibrillator (ICD)Cardiac Resynchronization Therapy Devices

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Maximal arm exercise capacity

The outcome will be evaluated using an arm ergometer exercise test. The test will begin with a 3-minute (unloaded) warm-up after rest. Different protocols will be applied to male and female patients due to differences in strength capabilities. Men will start rotating the ergometer with a 30-W workload, while women will start with a 20-W workload. In both protocols, patients will be asked to maintain a rotation speed of 70 revolutions per minute (rpm) throughout the test. Again, due to their different strength levels, the workload will be increased by 10W for men and 6W for women every minute.