Back to resultsEffect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper extremity aerobic exercise
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Heart Failure focused on measuring upper extremity aerobic exercise, functional exercise capacity, maximal exercise capacity, respiratory endurance, quality of life, dyspnea, pulmonary function, fatigue, anxiety, depression
Eligibility 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.
Sites / Locations
- Gazi University
- Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
upper extremity aerobic group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pulmonary function
Dynamic lung volume measurements will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.
Respiratory muscle strength
Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device.
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.
Peripheral muscle strength
It will be evaluated using a portable hand held Dynamometer.
Grip strength
It will be evaluated using a grip dynamometer.
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.
Physical activity level
Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.
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.
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.
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.
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).
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03675113
Brief Title
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
Official Title
Effects of Upper Extremity Aerobic Exercise Training on Exercise Capacity and Physical Activity Level in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
This study was a doctorate thesis and student changed the subject of her thesis.
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
upper extremity aerobic exercise, functional exercise capacity, maximal exercise capacity, respiratory endurance, quality of life, dyspnea, pulmonary function, fatigue, anxiety, depression
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
upper extremity aerobic group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Upper extremity aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Deep breathing exercises combinated with arm movements
Primary Outcome Measure Information:
Title
Maximal exercise capacity
Description
It will be evaluated using symptom limited cardiopulmonary exercise testing. The cardiopulmonary exercise test will be performed at a progressively increasing speed and grade
Time Frame
Second day
Secondary Outcome Measure Information:
Title
Pulmonary function
Description
Dynamic lung volume measurements will be performed using a spirometry according to the American Thoracic Society and European Respiratory Society criteria.
Time Frame
First day
Title
Respiratory muscle strength
Description
Maximal inspiratory and expiratory muscle strength will be evaluated a using mouth pressure device.
Time Frame
First day
Title
Pulmonary muscle endurance
Description
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.
Time Frame
First day
Title
Peripheral muscle strength
Description
It will be evaluated using a portable hand held Dynamometer.
Time Frame
First day
Title
Grip strength
Description
It will be evaluated using a grip dynamometer.
Time Frame
First day
Title
Functional impairment due to dyspnea
Description
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.
Time Frame
First day
Title
Physical activity level
Description
Physical activity will be evaluated multi sensor activity monitor for 4 consecutive days.
Time Frame
First day
Title
Functional exercise capacity
Description
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.
Time Frame
First day
Title
Activity daily of living
Description
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.
Time Frame
Second day
Title
Quality of sleep
Description
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.
Time Frame
Second day
Title
Fatigue
Description
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).
Time Frame
Second day
Title
Anxiety and depression
Description
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).
Time Frame
Second day
Title
Quality of life scale
Description
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).
Time Frame
Second day
Title
Dyspnea
Description
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.
Time Frame
Second day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanım Eda GÖKTAŞ, MSc
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meral BOŞNAK GÜÇLÜ, PhD
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adnan ABACI, PhD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Yenimahalle
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12860904
Citation
Giannuzzi P, Temporelli PL, Corra U, Tavazzi L; ELVD-CHF Study Group. Antiremodeling effect of long-term exercise training in patients with stable chronic heart failure: results of the Exercise in Left Ventricular Dysfunction and Chronic Heart Failure (ELVD-CHF) Trial. Circulation. 2003 Aug 5;108(5):554-9. doi: 10.1161/01.CIR.0000081780.38477.FA. Epub 2003 Jul 14.
Results Reference
background
PubMed Identifier
24622007
Citation
Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, Kitzman DW, Mancini DM, Rich MW. Cardiac rehabilitation exercise and self-care for chronic heart failure. JACC Heart Fail. 2013 Dec;1(6):540-7. doi: 10.1016/j.jchf.2013.09.002. Epub 2013 Oct 24.
Results Reference
background
PubMed Identifier
21697210
Citation
Antunes-Correa LM, Kanamura BY, Melo RC, Nobre TS, Ueno LM, Franco FG, Roveda F, Braga AM, Rondon MU, Brum PC, Barretto AC, Middlekauff HR, Negrao CE. Exercise training improves neurovascular control and functional capacity in heart failure patients regardless of age. Eur J Prev Cardiol. 2012 Aug;19(4):822-9. doi: 10.1177/1741826711414626. Epub 2011 Jun 22.
Results Reference
background
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Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure
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