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

NCT04803968 | Unknown

• 1 other identifier: 322
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Implantable cardiac defibrillator; Upper extremity endurance training; peak Oxygen consumption; upper extremity functional capacity

Outcome Measures

Primary Outcomes (4)

• Cardiorespiratory functional capacity

  Cardiopulmonary exercise test (CPET): It evaluates the aerobic capacity before the rehabilitation program and evaluates the responses to exercise and is used as the gold standard. A ramp bicycle ergometer test protocol will be applied for CPET. Parameters such as exercise duration, Watt, VO2, VCO2, blood pressure, heart rate, dyspnea, leg fatigue, general fatigue and effort perception according to the modified Borg scale, SaO2 will be saved at rest, AT (at anaerobic threshold), at peak level and at the end of the test in the recovery phase. At the end of the test, the reason for completing the test will be recorded. As one of the criteria for completing the test, attention will be paid to having the RER value of 1.05 and above. Results will be printed with 9 panel charts. (Gas analyzer; CORTEX METALYZER 3B Germany, bicycle; Lode Corival-cpet ERGOMETER, 12 channel ECG test system; Custo Cardio 200 BT system, Netherlands)

  Through study completion, an average of 1 year

• Arm ergometer endurance capacity

  The Lode Angio Arm Ergometer (with automatic stand, type: 917900 serial number:20160739, The Netherlands) device will be used for the arm ergometer test. It will start rotating the arm ergometer at 0 Watt (W) workload and at a speed of 60-75 rpm and will progress with a 10 W workload increase every 2 minutes. Modified Borg scores will be recorded for the patient's perception of arm fatigue and dyspnea before each workload increase. When the patient reaches one of the test termination criteria, the test will be terminated and the last achieved workload will be recorded as W and due to termination of the test.

  Through study completion, an average of 1 year

• 6 minute pegboard and ring test

  Participants will sit in front of a board with two top pegs, two bottom pegs and 10 rings on top of it. The lower pegs will be placed at the participant's shoulder height, and the upper pegs will be placed in the hole 20 cm above the lower pegs. Within a 6-minute period, participants will be asked to move as many rings as possible from the lower pegs to the upper pegs. Before and after each test, blood pressure, heart rate, SpO2 (Veron, VRN-502 pulse oximeter), dyspnea and arm fatigue detection (modified borg scale) will be recorded. The test will be performed a second time after the first test is completed, after a 30-minute interval or after the relevant variables return to their initial values. If the patient wants to rest during the test, they will be allowed but the stopwatch will not be stopped. During the test, patients will be encouraged every minute. The result of the test is the total number of rings carried.

  Through study completion, an average of 1 year

• Handgrip

  The measurements will be made in three repetitions for the right and left sides, with the shoulder in the sitting position, the elbow in 90 ° flexion, and the forearm in neutral position (Smedley Digital Hand Dynamometer, Model: 12-0286, Baseline, Fabrication Enterprises Inc (FEI), USA). For statistical analysis, the best values of the right and left sides and the arithmetic means of both sides will be recorded.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Quick DASH

  Through study completion, an average of 1 year

• The Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  Through study completion, an average of 1 year

• General Practice Physical Activity Questionnaire (GPPAQ)

  Through study completion, an average of 1 year

Study Arms (2)

control group

EXPERIMENTAL

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

Other: bicycle ergometer exercise

intervention group

EXPERIMENTAL

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

Other: bicycle ergometer and arm ergometer exercise

Interventions

bicycle ergometer and arm ergometer exercise 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.

intervention group

bicycle ergometer exercise 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.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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…).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hitit University: lead
• Hacettepe University: collaborator

Study Sites (1)

Hitit University

Çorum, 19030, Turkey (Türkiye)

RECRUITING

Central Study Contacts

AYŞE AKDAL

CONTACT

+905457198755; ayseakdal@hotmail.com

EBRU ÇALIK KÜTÜKCÜ

CONTACT

+903123052525; ebru.calik@hacettepe.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 18, 2021
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

TU (1)