Resistance Exercise Program and Branched Chain Amino Acid Supplementation in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Resistance Exercise; Dietary Supplement: RE and BCAA Supplementation

• Registration Number: NCT02240511
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary

Heart Failure (HF) is a complex syndrome which can include the physiological, neural hormonal and metabolic complications known as "Cardiac Cachexia" (CC). In the development of CC there is a release of catabolic cytokines (Tumor Necrosis Factor-α, interleukins 1 and 6)that cause a decrease of fat free mass and fat mass. These changes in body composition might be reversed with a therapeutic combination of resistance exercise and branched chain amino acid supplementation (BCAA). Thus the purpose of this study is evaluate changes in body composition after a resistance exercise program and BCAA supplementation in patients with HF.

Detailed Description

Heart failure (HF) is a complex syndrome which results from structural and/or functional alterations that limit the ability to respond to physiological demands(1,2).These abnormalities involve metabolic and neuro-hormonal factors such as tumor necrosis factor-α (TNF-α), one of the most important catabolic cytokines related with changes in body composition, interleukin 1 (IL-1), IL-6, interferon Y, and transmission growth factor β (3-9), which produce catabolic and anabolic imbalance and promote loss of fat free mass (FFM) with or without loss of fat mass (FM) in patients with HF. This syndrome is called "Cardiac Cachexia" (CC) (10). Signs and symptoms such as fatigue, anorexia and decreased muscle strength reflect altered body composition (9, 10). There are two possible ways to counteract these catabolic factors and restore body compartments. In one of them, protein supplementation promotes protein synthesis and inhibits proteolysis (3,11,12); in the other resistance exercise (RE) increases muscle mass and muscle strength, maintaining heart rate (13,14). Previous studies report the association of protein supplementation (15-17) and exercise (18-23) with changes in muscle strength in some cases and exercise capacity in HF patients. However, these therapies were not combined, and the studies did not provide enough information about changes in body composition. Based on these reports, our hypothesis is that the combination of RE and protein supplementation in form of branched chain amino acids (BCAA) might have an anabolic effect in patients with HF since the supplementation of BCAA could be helpful as "fuel" during the exercise and maintain the muscle mass metabolism (24).

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2014-09
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-12
• Last Update Submitted: 2014-09-12
• Study First Posted: 2014-09-15
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• More than 18 years
• Confirmed stable heart failure (2)

Exclusion Criteria

• No myocardial revascularization
• Unstable angina or stroke in the previous 3 months
• With no other chronic illness which contributed to loss of muscle mass (arthritis, renal failure, cancer, HIV) previous study inclusion
• Extra cardiac conditions that made patients unable to perform exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Exercise	Resistance Exercise	Resistance Exercise (RE) therapy was divided in four parts: stretching: arms, hands, wrists, legs, knees and ankles, each one for 10 - 20 seconds with resting intervals of 5 seconds (4 series), warming and flexion: the same muscle groups, making small circles forward and backward for 5 - 10 seconds with resting intervals of 5 seconds (4 series), resistance exercises: flexion, contractions and twisting of the same muscle groups worked in the two previous sections. In this part resistance was increased with the aid of dumbbells (500 g - 1500 g), barbells and bands, and patients performed the same exercises with 15 - 20 repetitions with resting intervals of 10 seconds. (4 series), relaxation: involved the same exercises as "stretching" to rest all muscle groups worked.
RE and BCAA Supplementation	RE and BCAA Supplementation	RE: Resistance Exercise Resistance Exercise therapy was the same as in the Active Comparator Branched Chain Aminoacids Amino 2000 BCAA (PRONAT® laboratory) supplementation group received 180 packets of 5 grams (g)and ingested 10 g/day (5 g after breakfast and 5 g before RE)

Primary Outcome Measures

Name	Time	Method
Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation.	Baseline, 3 month

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Distrito Federal, Mexico