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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Recruitment Status : Withdrawn (This study was a doctorate thesis and student changed the subject of her thesis.)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
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Other: Upper extremity aerobic exercise Other: Control Group Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Respiratory muscle strength [ Time Frame: First day ]
    Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device.

  3. 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.

  4. Peripheral muscle strength [ Time Frame: First day ]
    It will be evaluated using a portable hand held Dynamometer.

  5. Grip strength [ Time Frame: First day ]
    It will be evaluated using a grip dynamometer.

  6. 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.

  7. Physical activity level [ Time Frame: First day ]
    Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Turkey
Gazi University
Ankara, Yenimahalle, Turkey, 06500
Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Ankara, Turkey, 06500
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Hanım Eda GÖKTAŞ, MSc Gazi University
Study Director: Meral BOŞNAK GÜÇLÜ, PhD Gazi University
Principal Investigator: Adnan ABACI, PhD Gazi University
Publications:
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Responsible Party: Meral Boşnak Güçlü, associate professor, Gazi University
ClinicalTrials.gov Identifier: NCT03675113    
Other Study ID Numbers: Gazi University 14
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meral Boşnak Güçlü, Gazi University:
upper extremity aerobic exercise
functional exercise capacity
maximal exercise capacity
respiratory endurance
quality of life
dyspnea
pulmonary function
fatigue
anxiety
depression
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases