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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Changes in Body Composition in Heart Failure Patients After a Resistance Exercise Program and Branched Chain Amino Acid Supplementation

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: RE and BCAA Supplementation
* Other: Resistance Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resistance Exercise<br>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. | Other: Resistance Exercise<br> <br> |
| Experimental: RE and BCAA Supplementation<br>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) | Dietary Supplement: RE and BCAA Supplementation<br>* RE: Resistance Exercise BCAA: Branched Chain Aminoacids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation. |  | Baseline, 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistance Exercise, Body Composition, Amino Acids Supplementation