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

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ClinicalTrials.gov Identifier: NCT03644836
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 21, 2015
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. maximum oxygene uptake [ Time Frame: after 6 weeks of treatment ]
    maximum oxygene uptake measured during intensive exercise



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644836


Locations
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France
Chu de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Jean-Claude MEURICE Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03644836     History of Changes
Other Study ID Numbers: REHABAAR
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases