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

NCT ID: NCT03675113

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2020-12-31

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Upper extremity aerobic exercise

Intervention Type: OTHER

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.

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.

Group Type: SHAM_COMPARATOR

Control Group

Intervention Type: OTHER

Deep breathing exercises combinated with arm movements

Interventions

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.

Intervention Type: OTHER

Control Group

Deep breathing exercises combinated with arm movements

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Meral Boşnak Güçlü

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanım Eda GÖKTAŞ, MSc

Role: STUDY_CHAIR

Gazi University

Meral BOŞNAK GÜÇLÜ, PhD

Role: STUDY_DIRECTOR

Gazi University

Adnan ABACI, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 12860904 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24622007 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21697210 (View on PubMed)

Other Identifiers

Gazi University 14

Identifier Type: -

Identifier Source: org_study_id