Broncho Chronic Obstructive Pulmonary Disease Clinical Trial
— REHABAAROfficial title:
Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease. Randomized Study Against Placebo
NCT number | NCT03644836 |
Other study ID # | REHABAAR |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 21, 2015 |
Est. completion date | March 5, 2018 |
Verified date | February 2019 |
Source | Poitiers University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 5, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Chu de Poitiers | Poitiers |
Lead Sponsor | Collaborator |
---|---|
Poitiers University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximum oxygene uptake | maximum oxygene uptake measured during intensive exercise | after 6 weeks of treatment |