An interventional study of bicycle ergometer and arm ergometer exercise and bicycle ergometer exercise in Heart Failure With Reduced Ejection Fraction, sponsored by Hitit University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 45 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
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Exclusion Criteria:
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
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
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.
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.
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
Quick DASH
It is an abbreviation of the 30-item Quick-DASH questionnaire used to evaluate one or more musculoskeletal physical functions and symptoms of the upper extremity. It consists of 11 items. The results of the questionnaire will be evaluated on a 100 point scale and higher scores will indicate the presence of more disability.
Time frame: Through study completion, an average of 1 year
The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
The MLHFQ consists of 21 items and measures three important dimensions (physical, socioeconomic and psychological) of quality of life in patients with heart failure. It is scored with a 6-point Likert scale graded as 0 (no effect / not valid, best score) -5 (severe impact, worst score) within an average of 5 minutes. It can be applied by itself or by an interviewer. The total score of the scale for 21 questions ranges from 0 to 105, and higher scores indicate a lower quality of life. The patients' quality of life will be evaluated with the "Minnesota Heart Failure Life Questionnaire", which measures the quality of life specific to heart failure. The Turkish validity and reliability of the questionnaire has been done.
Time frame: Through study completion, an average of 1 year
General Practice Physical Activity Questionnaire (GPPAQ)
The "General Practice Physical Activity Questionnaire" (GPPAQ), which was developed to evaluate the physical activity level of adults in primary care, consists of seven questions under three main headings. It is a scale that takes about 30-60 seconds to fill. In the first part of the scale, a question is asked about the mobility of the person in the workplace, while the second part is asked about the activities performed in the last seven days and how many hours per week. In the last part, there is a question that evaluates the normal walking speed of the person.
Time frame: Through study completion, an average of 1 year
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