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

NCT ID: NCT03644836

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-21
• Study Completion Date: 2018-03-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Retraining with respiratory effort+ amino acids

Group Type: EXPERIMENTAL

Amino Acids

Intervention Type: DRUG

Sweet taste cocoa flavored drink

Retraining with respiratory effort+ placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Sweet taste cocoa flavored drink

Interventions

Amino Acids

Sweet taste cocoa flavored drink

Intervention Type: DRUG

Placebos

Sweet taste cocoa flavored drink

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Claude MEURICE

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

Chu de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

REHABAAR

Identifier Type: -

Identifier Source: org_study_id