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

NCT ID: NCT04803968

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control group

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

Group Type: EXPERIMENTAL

bicycle ergometer exercise

Intervention Type: OTHER

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.

intervention group

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

Group Type: EXPERIMENTAL

bicycle ergometer and arm ergometer exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Ayşe Akdal

physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hitit University

Çorum, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

AYŞE AKDAL

Role: CONTACT

ayseakdal@hotmail.com

+905457198755

EBRU ÇALIK KÜTÜKCÜ

Role: CONTACT

ebru.calik@hacettepe.edu.tr

+903123052525 ext. 195

Other Identifiers

322

Identifier Type: -

Identifier Source: org_study_id