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Antioxidants and Pulmonary Rehabilitation in COPD Patients (AREB-1)

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, exercise training, pulmonary rehabilitation, antioxidant, muscle

Eligibility Criteria

40 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD patients, 40 years to 78 years, last exacerbation dating at least 4 weeks

Exclusion Criteria:

  • unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
  • nutritional supplementation in the 4 weeks preceding the study (antioxidant, vitamins…)

Sites / Locations

  • Clinique du souffle la vallonie
  • University Hospital of Montpellier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Antioxidant Supplementation

Placebo

Arm Description

Vitamin antioxidant and trace elements combination that won't exceed the maximal nutritional dose recommended in France (Vit E, vit C, Selenomethionine, Zinc gluconate).

Placebo

Outcomes

Primary Outcome Measures

quadriceps endurance time.Time frame: at the start and the end of the study
sitting on a bench, starting from a 90° knee flexion of the dominant leg, the subjects should perform knee extensions (6 movements per minute) with a workload to 30% of the isometric maximal voluntary contraction until exhaustion. The duration of the test (in seconds) characterizes the quadriceps endurance.

Secondary Outcome Measures

muscle and /or serum oxidative stress level
Description: oxidative stress will be evaluated by measuring lipid peroxidation and oxidized proteins.GSH/ GSSG ratio and enzymatic/non enzymatic antioxidants
Isometric maximal voluntary contraction of the quadriceps
sitting on a bench with a force sensor connected to a data acquisition and analysis system signal, subjects should reproduce three trials spaced 1 minute, by an extension movement of the knee joint against a stationary load, maximum way, keeping the arms crossed over the chest and leaning against the back in order to limit the involvement of other muscles. The most elevated of the three tests repeatable value close to 10% characterizes the maximum strength of subjects.

Full Information

First Posted
August 14, 2013
Last Updated
August 14, 2018
Sponsor
University Hospital, Montpellier
Collaborators
5 Santé
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1. Study Identification

Unique Protocol Identification Number
NCT01942889
Brief Title
Antioxidants and Pulmonary Rehabilitation in COPD Patients
Acronym
AREB-1
Official Title
Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
5 Santé

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits
Detailed Description
COPD will constitute the third cause of mortality in 2012. This chronic respiratory disease is characterized by peripheral dysfunction of skeletal muscle which is associated with major clinical outcomes (prognostics, symptoms, and health related quality of life). Muscle and systemic oxidative stress has been incriminated in this peripheral muscle dysfunction.Exercise training constitute the main validated therapeutic intervention leading to significant muscle function and clinical improvement.Our preliminary results have shown that COPD patients experiment dietary and enzymatic antioxidants defects.Yet, generic antioxidant supplementation has not shown significant muscle function improvement.Therefore, we aim to test the effects of an antioxidant supplementation targeted on the antioxidant defects associated with exercise training on the peripheral muscle function, exercise tolerance and health quality of life in COPD patients.At the cellular level, this muscle dysfunction is related with a fiber atrophy and a metabolic switch (reduce proportion of oxidative fiber).This study will compare the effects of an antioxidant supplementation on the peripheral muscle function and skeletal muscle cellular properties in association with exercise training during a pulmonary rehabilitation course.Volunteers will be randomised in 2 groups: - 1 group treated with the antioxidant supplementation ( 28 days)- 1 group treated with the placeboIntervention will be allocated by chance and a double blind manner. Antioxidant supplementation will associate vitamins and trace elements that won't exceed the maximal nutritional dose recommended.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD
Keywords
COPD, exercise training, pulmonary rehabilitation, antioxidant, muscle

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antioxidant Supplementation
Arm Type
Active Comparator
Arm Description
Vitamin antioxidant and trace elements combination that won't exceed the maximal nutritional dose recommended in France (Vit E, vit C, Selenomethionine, Zinc gluconate).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program
Intervention Description
Vit E, Vit C, Selenomethionine, Zinc gluconate
Primary Outcome Measure Information:
Title
quadriceps endurance time.Time frame: at the start and the end of the study
Description
sitting on a bench, starting from a 90° knee flexion of the dominant leg, the subjects should perform knee extensions (6 movements per minute) with a workload to 30% of the isometric maximal voluntary contraction until exhaustion. The duration of the test (in seconds) characterizes the quadriceps endurance.
Time Frame
up to day 37
Secondary Outcome Measure Information:
Title
muscle and /or serum oxidative stress level
Description
Description: oxidative stress will be evaluated by measuring lipid peroxidation and oxidized proteins.GSH/ GSSG ratio and enzymatic/non enzymatic antioxidants
Time Frame
up to day 37
Title
Isometric maximal voluntary contraction of the quadriceps
Description
sitting on a bench with a force sensor connected to a data acquisition and analysis system signal, subjects should reproduce three trials spaced 1 minute, by an extension movement of the knee joint against a stationary load, maximum way, keeping the arms crossed over the chest and leaning against the back in order to limit the involvement of other muscles. The most elevated of the three tests repeatable value close to 10% characterizes the maximum strength of subjects.
Time Frame
up to day 37

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD patients, 40 years to 78 years, last exacerbation dating at least 4 weeks Exclusion Criteria: unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric) nutritional supplementation in the 4 weeks preceding the study (antioxidant, vitamins…)
Facility Information:
Facility Name
Clinique du souffle la vallonie
City
Lodève
ZIP/Postal Code
34700
Country
France
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31178967
Citation
Gouzi F, Maury J, Heraud N, Molinari N, Bertet H, Ayoub B, Blaquiere M, Bughin F, De Rigal P, Poulain M, Pincemail J, Cristol JP, Laoudj-Chenivesse D, Mercier J, Prefaut C, Pomies P, Hayot M. Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Apr 17;2019:5496346. doi: 10.1155/2019/5496346. eCollection 2019.
Results Reference
derived

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Antioxidants and Pulmonary Rehabilitation in COPD Patients

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