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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2019
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Amino Acids
Sweet taste cocoa flavored drink
Placebos
Sweet taste cocoa flavored drink

Locations

Country Name City State
France Chu de Poitiers Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum oxygene uptake maximum oxygene uptake measured during intensive exercise after 6 weeks of treatment