The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD

Hitit University

Status: Unknown

Conditions: Heart Failure With Reduced Ejection Fraction

Treatments: Other: bicycle ergometer exercise; Other: bicycle ergometer and arm ergometer exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04803968

322

Details and patient eligibility

About

It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failure patients with ICD.

Full description

Pacemaker (permanent battery) is implanted in patients for many reasons. For reasons such as symptomatic bradycardia and AV block, a pacemaker with modes such as VVR and DDDR designed for pacing only when the pulse decreases can be implanted. At the same time, pacemakers can be implanted in VR-ICD, DR-ICD modes, which have the ability to recognize fatal rhythm problems such as Ventricular tachycardia (VT) / Ventricular Fibrillation (VF) and perform intracardiac defibrillation (ICD).

Pacemakers are positioned by opening a pocket under the patient's left pectoral muscle.Cables coming out of the battery (leads) are placed in the right ventricle, right atrium or coronary sinuses via active or passive fixation through the left subclavian vein. In the early period after pacemaker implantation, patients are warned to avoid movements that force the extremity on that side so that the leads and battery are affected by extremity movements and their positions and functions are not impaired.

Many pacemaker patients prolong this period too much (> 3 months), causing them to develop left extremity muscle-joint dysfunction. This situation can also affect the functional capacity of the patients.ICD pacemakers are larger in size than conventional pacemakers due to their functions, so they are placed in a larger pocket in the pectoral area.These patients are warned more strictly about coercive movements.

The aim of this study is to investigate the effect of arm ergometer endurance training on functional capacity and upper extremity function in heart failure patients with ICD included in cardiac rehabilitation program, and to examine the effect on battery and leads as safety parameters.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of heart failure in the New York Heart Association (NYHA) class II-III, who have had at least 3 months past ICD implantation, and who did not have any complications at the last pacemaker control,
• Ejection fraction (EF) value ≤45%,
• The medicines used have not been changed for at least 3 months,
• Volunteering to participate in the research, being able to attend a 1-hour rehabilitation program every day of the week,
• To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
• Not having any orthopedic problems that may prevent him from exercising with his bicycle and arm ergometer,
• CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECHO without any obstacle to exercise within the framework of TKD cardiology guidelines (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT...).

Exclusion criteria

• Those with a history of shoulder injury (severe pain around the shoulder and inability to move, severe swelling around the shoulder, shoulder dislocation)
• Those with a history of shoulder surgery,
• Sequelae of a cerebrovascular accident with mastectomy or arm involvement on the affected side,
• Having decompensated heart failure,
• Having an obstacle to exercise within the framework of TSC (Turkish Society of Cardiology) cardiology guidelines in CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECO (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT ...)
• Having a history of ICD shock in the last 6 months,
• Having an active treated malignancy or a collagen tissue disease receiving systemic steroids
• Being unable to cooperate or adapt to exercise due to cerebrovascular disease or other reasons,
• Having a chronic kidney disease undergoing dialysis where the volume load is not stable.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

control group

Experimental group

Description:

After the evaluations are completed, the participants will be randomly divided into two groups using a computer-assisted randomization program. The cardiac rehabilitation program will be a total of 30 sessions, 5 days a week x 6 weeks. All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training

Treatment:

Other: bicycle ergometer exercise

intervention group

Experimental group

Description:

The combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group.

Treatment:

Other: bicycle ergometer and arm ergometer exercise