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

Sponsor

Poitiers University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03644836

Collaborator

(none)

Enrollment

Location

Arms

37.4

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Broncho Chronic Obstructive Pulmonary Disease	Drug: Amino Acids Drug: Placebos	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 21, 2015

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Mar 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Retraining with respiratory effort+ amino acids	Drug: Amino Acids Sweet taste cocoa flavored drink
Placebo Comparator: Retraining with respiratory effort+ placebo	Drug: Placebos Sweet taste cocoa flavored drink

Arm

Intervention/Treatment

Experimental: Retraining with respiratory effort+ amino acids

Drug: Amino Acids

Sweet taste cocoa flavored drink

Placebo Comparator: Retraining with respiratory effort+ placebo

Drug: Placebos

Sweet taste cocoa flavored drink

Outcome Measures

Primary Outcome Measures

maximum oxygene uptake [after 6 weeks of treatment]
maximum oxygene uptake measured during intensive exercise

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu de Poitiers	Poitiers		France	86021

Sponsors and Collaborators

Poitiers University Hospital

Investigators

Principal Investigator: Jean-Claude MEURICE, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT03644836

Other Study ID Numbers:

REHABAAR

First Posted:

Aug 23, 2018

Last Update Posted:

Feb 20, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Feb 20, 2019