Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease

NCT03644836 | Completed

• 1 other identifier: REHABAAR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory rehabilitation is one of the main treatments for COPD in the early stages of the disease (Stage 2 of GOLD) with a recognized effect on improving the capacity of the patients to exert effort by fighting against deconditioning. the effort. This treatment also improves the quality of life of patients and reduces the risk of respiratory exacerbations. The patients are very often malnourished and various studies have proposed the addition of oral supplementation such as hormone therapy (testosterone) to improve the exercise performance of these atrophied muscles. The use of branched-chain amino acids (AARs) such as valine, leucine, isoleucine in this indication can be fully justified because they stimulate protein synthesis and promote muscle maintenance and repair.

Conditions

Broncho Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• maximum oxygene uptake

  maximum oxygene uptake measured during intensive exercise

  after 6 weeks of treatment

Study Arms (2)

Retraining with respiratory effort+ amino acids

EXPERIMENTAL

Drug: Amino Acids

Retraining with respiratory effort+ placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Amino Acids DRUG

Sweet taste cocoa flavored drink

Retraining with respiratory effort+ amino acids

Placebos DRUG

Sweet taste cocoa flavored drink

Retraining with respiratory effort+ placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Broncho Chronic Obstructive Pulmonary Disease in stages 2 and 3 of the GOLD classification, whose Maximum Expiratory Volume on the first second is between 30% and 80% of the expected theoretical value, associated with a maximal expiratory volume ratio on the first Second / Vital Capacity less than or equal to 70% of the expected theoretical value.
• Patients of both sexes, aged 40 to 80 years
• In case of active smoking, patients must commit to interrupting it during the respiratory rehabilitation program that will be proposed to them in this study

You may not qualify if:

• \- Age \<40 years or\> 80 years
• Patients with a contraindication to exercise,
• Phenylketonuria
• Patients treated with long-term oxygen therapy and / or home ventilation will not be included.
• Patients with known allergy to milk, gluten, soy, egg and nuts
• Patients taking part in another clinical trial or who have participated in a clinical trial in the 3 months preceding this study.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Chu de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Interventions

Amino Acids

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Jean-Claude MEURICE

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 23, 2018
• Study Start: January 21, 2015
• Primary Completion: January 31, 2018
• Study Completion: March 5, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)