NCT04803968

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

The Effect of Upper Extremity Endurance Training Applied in Addition to Lower Extremity Endurance Training on Functional Capacity and Pacemaker Functions in Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Hitit University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
OTHER	bicycle ergometer and arm ergometer exercise	After the bicycle ergometer training is completed, there will be a 15-minute break for blood pressure measurement of the patients. Then the combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group. For this, the patient will sit upright in front of the height-adjustable arm ergometer stand (Lode Angio Arm Ergometer with Automat) with the fulcrum of the handle at shoulder height. The arm endurance training group will work for a total of 20 minutes, at 60% of the peak workload and at 50 rpm.
OTHER	bicycle ergometer exercise	All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training (Lode Corival Cpet Ergoline type: 960900 serial number: 20160094, Netherlands). The exercise protocol for the lower extremities will consist of a total of 40 minutes, including an 8-minute warm-up phase and an 8-minute cool-down phase. Exercise intensity, on the other hand, will be arranged as recommended in the European Society of Cardiology (ESC) 2020 guideline for chronic heart failure patients, at a workload corresponding to 70-80% of peak oxygen consumption (VO2peak), with a turnover rate of 60 cycles / min.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2021-03-18
• Last updated: 2021-04-01

Locations

1 site across 1 country: Turkey (Türkiye)