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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exercise Intolerance in Elderly Patients With HFpEF(Heart Failure With Preserved Ejection Fraction)

NCT02636439

Heart Failure, Diastolic Obesity

COMPLETED NA

Exercise Intervention in Patients With Heart Failure With Preserved and Reduced Ejection Fraction

NCT05255172

Heart Failure New York Heart Association (NYHA) Class II Heart Failure New York Heart Association (NYHA) Class III

ENROLLING_BY_INVITATION NA

Resistance Training in HFpEF

NCT02435667

Heart Failure Preserved Ejection Fraction

COMPLETED NA

Clinical Relevance of Different Training Intensities in Chronic Heart Failure.

NCT05213546

Chronic Heart Failure

COMPLETED NA

Resistance Exercise With Blood Flow Restriction by Vascular Occlusion on Myocardial Function in Heart Failure With Reduced Ejection Fraction

NCT07118410

Heart Failure Ventricular Function, Left

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Resistance Exercise

Intervention Type OTHER

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)

Group Type EXPERIMENTAL

RE and BCAA Supplementation

Intervention Type DIETARY_SUPPLEMENT

RE: Resistance Exercise BCAA: Branched Chain Aminoacids

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RE and BCAA Supplementation

RE: Resistance Exercise BCAA: Branched Chain Aminoacids

Intervention Type DIETARY_SUPPLEMENT

Resistance Exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

LILIA CASTILLO MARTINEz

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR