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

NCT03675113 | Withdrawn

• 1 other identifier: Gazi University 14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Pulmonary function

  First day

• Respiratory muscle strength

  First day

• Pulmonary muscle endurance

  First day

• Peripheral muscle strength

  First day

• Grip strength

  First day

Study Arms (2)

upper extremity aerobic group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

Interventions

Upper extremity aerobic exercise 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.

upper extremity aerobic group

Control Group OTHER

Deep breathing exercises combinated with arm movements

control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Gazi University

Ankara, Yenimahalle, 06500, Turkey (Türkiye)

Location

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 12860904 BACKGROUND

• 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.

  PMID: 24622007 BACKGROUND

• 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.

  PMID: 21697210 BACKGROUND

MeSH Terms

Conditions

Dyspnea; Fatigue; Anxiety Disorders; Depression

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hanım Eda GÖKTAŞ, MSc

  Gazi University

  STUDY CHAIR

• Meral BOŞNAK GÜÇLÜ, PhD

  Gazi University

  STUDY DIRECTOR

• Adnan ABACI, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 18, 2018
• Study Start: September 5, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)