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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: Upper extremity aerobic exercise; Other: Control Group

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06500
    • Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06500
      • Gazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Meral Boşnak Güçlü, PhD, Gazi University; Study Chair: Hanım Eda GÖKTAŞ, MSc, Gazi University; Principal Investigator: Adnan ABACI, PhD, Gazi University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; quality of life; depression; anxiety; pulmonary function; dyspnea; upper extremity aerobic exercise; functional exercise capacity; maximal exercise capacity; respiratory endurance
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Gazi University 14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No