Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure

Study Overview
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Brief Summary
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Heart failure is a cardiac structural or functional disorder that, despite normal filling pressures, leads to inability to deliver enough oxygen to meet the metabolic needs o tissue. Heart failure is a serious chronic condition that affects a large proportion of the adult population in the world causing high mortality, leading to exercise intolerance and reduced health-related quality of life. Patients included in the cardiac rehabilitation program slow down disease progression, hospitalization decreases, quality of life improves and health expenditures decrease. Despite the frequent use of upper extremities in daily living activities, studies investigating the effect of upper extremity aerobic training on daily living activities, functional exercise capacity and other outcomes are limited. No studies have investigated the effect of upper extremity aerobic exercise training on physical activity level, functional and maximal exercise capacity and other measures in patients with heart failure.

Detailed Description
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It has been reported that exercise capacity in peak arm exercise is almost 30% lower in heart failure patients. For this reason intolerance to arm exercise is a significant problem in heart failure patients and may contribute to a decrease in performance in activities of daily living. Considering the fact that developments in these patients are caused by vasculature functional adaptation the extremity skeletal muscle and applied limbs, upper extremity exercises may be useful to reduce exercise intolerance during activities requiring continuous arm movement.

Official Title
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Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity and Physical Activity Level in Patients With Chronic Heart Failure

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: Upper extremity aerobic exercise
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of chronic heart failure diagnosed at rest below 40% of the left ventricular ejection fraction and class 1-3 according to the New York Heart Association classification Optimal medical treatment at least 30 days and clinically stable Exclusion Criteria: Patients with unstable angina pectoris Decompensated heart failure Primary pulmonary hypertension Complex ventricular arrhythmia Contraindication to cardiopulmonary exercise testing Patients who have had myocardial ischemia in the past 3 months Ischemic cerebrovascular events Second and third degree atrioventricular block Thrombus detected in the left ventricle Uncontrolled insulin dependent diabetes mellitus Uncontrolled hypertension Renal insufficiency Acute infection Aortic stenosis Acute pulmonary embolism Mental, musculoskeletal, neurological, or systemic illness that will prevent exercise.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: upper extremity aerobic group<br>The upper extremity aerobic exercise training with an arm ergometer will be performed in the treatment group so that training intensity will be between 60% and 80% of the maximum heart rate, dyspnea perception will be 3-4 according to Modified Borg Scale and fatigue perception will be 5-6 according to Modified Borg Scale, training duration will be 3 day per a week through 6-weeks. | Other: Upper extremity aerobic exercise<br>* Range of maximal heart rate will be followed by a polar band during supervised session each week. Aerobic exercise will be trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department.<br>|
| Sham Comparator: control group<br>Deep breathing exercises combination with arm movements will be given as a home program in the control group. Training duration will be 3 day per a week through 6-weeks. | Other: Control Group<br>* Deep breathing exercises combinated with arm movements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal exercise capacity | It will be evaluated using symptom limited cardiopulmonary exercise testing. The cardiopulmonary exercise test will be performed at a progressively increasing speed and grade | Second day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function | Dynamic lung volume measurements will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria. | First day | 
| Respiratory muscle strength | Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device. | First day | 
| Pulmonary muscle endurance | It will be evaluated incremental threshold loading test, in which participants started an initial load of 30% of maximal inspiratory pressure with a 10% increment every 2 minutes. | First day | 
| Peripheral muscle strength | It will be evaluated using a portable hand held Dynamometer. | First day | 
| Grip strength | It will be evaluated using a grip dynamometer. | First day | 
| Functional impairment due to dyspnea | It will be evaluated with modified Medical Research Council Dyspnea Scale (MMRC). MMRC is a baseline assessment of functional impairment attributable to dyspnea from respiratory disease. modiﬁed Medical Research Council (mMRC) Dyspnea Scale, which consist of ﬁve-item scale based on a variety of physical activities that cause a feeling of dyspnea, was used to determine the severity of patients' shortness of breath. The participants read and chose the most appropriate scale option between 0 and 4 that best describes the degree of their pulmonary distress. | First day | 
| Physical activity level | Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days. | First day | 
| Functional exercise capacity | Six minute pegboard and ring test (6-PBRT) was applied to assess the functional capacity of the upper limbs. Subjects are asked to move as many rings as possible in 6 minutes, and the score is the number of rings moved during the 6-minute period. | First day | 
| Activity daily of living | London Chest Activity Daily of Living Scale is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items).The total score is calculated by summing the domains and ranges from 0 to 75, with higher values indicating more marked limitation in activity daily of living performance. | Second day | 
| Quality of sleep | Pittsburgh Sleep Quality Index (Turkish version) (PSQI) is a self-reported questionnaire. PSQI evaluates patients' sleep quality. The scale includes 24 questions overall, with 19 questions answered by the person him/ herself and the remaining 5 answered by his/her bed partner or roommate. The first 19 self-answered questions evaluate 7 subscales, subjective sleep quality, sleep latency, duration of sleep, routine sleep activity, sleep disorders, the use of drugs for sleeping, and daytime dysfunction. Each item in the scale is scored between 0 and 3 (no difficulty to severe difficulty). The sum of the 7 subscale scores gives the overall PSQI score. Lower scores show better sleep quality. | Second day | 
| Fatigue | Fatigue Severity Scale (Turkish version) - Fatigue Severity Scale (FSS) is a self-reported questionnaire. FSS evaluates patient's fatigue severity. This questionnaire includes 9 items and score range for each item from 1 to 7 point (7-point Likert scale). Fatigue Severity Scale score is calculates by deriving an arithmetic mean. Cut-scores of over 4 are indicative of significant fatigue (higher scores show more severe fatigue). | Second day | 
| Anxiety and depression | Hospital Anxiety and Depression (Turkish version). The test used to determine the risk group of patients in terms of anxiety and depression and consists of 14 questions. Lowest score that patients can get from both subscales is 0, the highest score 21. The cut-off points for the Turkish version of the HAD scale were 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D). | Second day | 
| Quality of life scale | Minnesota Living with Heart Failure Questionnaire (MLHFQ) (Turkish version of scale) 21 items rated on six-point Likert scales, representing different degrees of impact of heart failure on Heart Related Quality of Life (HRQoL), from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). | Second day | 
| Dyspnea | It will be evaluated modified Borg Scale. This modified 12-point scale consists (0, 0.5, 1-10) corresponds with increasing shortness of breath. Patients were asked to mark the most appropriate description or number of their shortness of breath at rest and during exercise. | Second day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper extremity aerobic exercise, functional exercise capacity, maximal exercise capacity, respiratory endurance, quality of life, dyspnea, pulmonary function, fatigue, anxiety, depression