Clinical trial NCT03675113: 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
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Second day
Secondary outcomes:
measure: Pulmonary function
timeFrame: First day
measure: Respiratory muscle strength
timeFrame: First day
measure: Pulmonary muscle endurance
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Grip strength
timeFrame: First day
measure: Functional impairment due to dyspnea
timeFrame: First day
measure: Physical activity level
timeFrame: First day
measure: Functional exercise capacity
timeFrame: First day
measure: Activity daily of living
timeFrame: Second day
measure: Quality of sleep
timeFrame: Second day
measure: Fatigue
timeFrame: Second day
measure: Anxiety and depression
timeFrame: Second day
measure: Quality of life scale
timeFrame: Second day
measure: Dyspnea
timeFrame: Second day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Hanım Eda GÖKTAŞ, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, PhD
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Adnan ABACI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.