Back to resultsInterest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease (REHABAAR)
Primary Purpose
Broncho Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Amino Acids
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Broncho Chronic Obstructive Pulmonary Disease
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.
Sites / Locations
- Chu de Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Retraining with respiratory effort+ amino acids
Retraining with respiratory effort+ placebo
Arm Description
Outcomes
Primary Outcome Measures
maximum oxygene uptake
maximum oxygene uptake measured during intensive exercise
Secondary Outcome Measures
Full Information
NCT ID
NCT03644836
First Posted
August 6, 2018
Last Updated
February 19, 2019
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03644836
Brief Title
Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease
Acronym
REHABAAR
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2015 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Broncho Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retraining with respiratory effort+ amino acids
Arm Type
Experimental
Arm Title
Retraining with respiratory effort+ placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Amino Acids
Intervention Description
Sweet taste cocoa flavored drink
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Sweet taste cocoa flavored drink
Primary Outcome Measure Information:
Title
maximum oxygene uptake
Description
maximum oxygene uptake measured during intensive exercise
Time Frame
after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude MEURICE
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease
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