Completed

NCT Number: NCT03644836

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Broncho Chronic Obstructive Pulmonary Disease

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

- 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 acute respiratory decompensation in the three months prior to inclusion.
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.

Treatment and study plan

Amino Acids

Drug

Sweet taste cocoa flavored drink

Placebos

Drug

Sweet taste cocoa flavored drink

Primary outcomes

maximum oxygene uptake

Time frame: after 6 weeks of treatment

maximum oxygene uptake measured during intensive exercise

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease. Randomized Study Against Placebo

Acronym: REHABAAR

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Aug 23, 2018
Registry last updated: Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.