Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
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|ClinicalTrials.gov Identifier: NCT03675113|
Recruitment Status : Withdrawn (This study was a doctorate thesis and student changed the subject of her thesis.)
First Posted : September 18, 2018
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Other: Upper extremity aerobic exercise Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity and Physical Activity Level in Patients With Chronic Heart Failure|
|Actual Study Start Date :||September 5, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: upper extremity aerobic group
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
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.
Sham Comparator: control group
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
Deep breathing exercises combinated with arm movements
- Maximal exercise capacity [ Time Frame: Second day ]It will be evaluated using symptom limited cardiopulmonary exercise testing. The cardiopulmonary exercise test will be performed at a progressively increasing speed and grade
- Pulmonary function [ Time Frame: First day ]Dynamic lung volume measurements will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.
- Respiratory muscle strength [ Time Frame: First day ]Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device.
- Pulmonary muscle endurance [ Time Frame: First day ]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.
- Peripheral muscle strength [ Time Frame: First day ]It will be evaluated using a portable hand held Dynamometer.
- Grip strength [ Time Frame: First day ]It will be evaluated using a grip dynamometer.
- Functional impairment due to dyspnea [ Time Frame: First day ]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.
- Physical activity level [ Time Frame: First day ]Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.
- Functional exercise capacity [ Time Frame: First day ]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.
- Activity daily of living [ Time Frame: Second day ]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.
- Quality of sleep [ Time Frame: Second day ]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.
- Fatigue [ Time Frame: Second day ]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).
- Anxiety and depression [ Time Frame: Second day ]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).
- Quality of life scale [ Time Frame: Second day ]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).
- Dyspnea [ Time Frame: Second day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675113
|Ankara, Yenimahalle, Turkey, 06500|
|Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation|
|Ankara, Turkey, 06500|
|Study Chair:||Hanım Eda GÖKTAŞ, MSc||Gazi University|
|Study Director:||Meral BOŞNAK GÜÇLÜ, PhD||Gazi University|
|Principal Investigator:||Adnan ABACI, PhD||Gazi University|