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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
RE and BCAA Supplementation
Resistance Exercise
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Body Composition, Amino Acids Supplementation, Resistance Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Resistance Exercise

RE and BCAA Supplementation

Arm Description

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: 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)

Outcomes

Primary Outcome Measures

Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2014
Last Updated
September 12, 2014
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02240511
Brief Title
Resistance Exercise Program and Branched Chain Amino Acid Supplementation in Heart Failure Patients
Official Title
Changes in Body Composition in Heart Failure Patients After a Resistance Exercise Program and Branched Chain Amino Acid Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Body Composition, Amino Acids Supplementation, Resistance Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RE and BCAA Supplementation
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
RE and BCAA Supplementation
Intervention Description
RE: Resistance Exercise BCAA: Branched Chain Aminoacids
Intervention Type
Other
Intervention Name(s)
Resistance Exercise
Primary Outcome Measure Information:
Title
Evaluate changes in body composition in heart failure patients after a resistance exercise program and branched chain aminoacids supplementation.
Time Frame
Baseline, 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A Pineda, MSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nestor A Sánchez, MSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lilia Castillo, PhD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arturo Orea, MD
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rocio Cervantes, Ms
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Keirns D Candace, MD
Organizational Affiliation
Massachusetts General Hospital Interpreter Services
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Ocampo, Mr
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karla Quiroz, Ms
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mónica Tenorio, Ms
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alberto Ronquillo, Mr
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25726428
Citation
Pineda-Juarez JA, Sanchez-Ortiz NA, Castillo-Martinez L, Orea-Tejeda A, Cervantes-Gaytan R, Keirns-Davis C, Perez-Ocampo C, Quiroz-Bautista K, Tenorio-Dupont M, Ronquillo-Martinez A. Changes in body composition in heart failure patients after a resistance exercise program and branched chain amino acid supplementation. Clin Nutr. 2016 Feb;35(1):41-47. doi: 10.1016/j.clnu.2015.02.004. Epub 2015 Feb 14.
Results Reference
derived

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

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