Antioxidants and Pulmonary Rehabilitation in COPD Patients

NCT01942889 | Completed

• 1 other identifier: 8710
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Obstructive Pulmonary Disease; COPD

Keywords

COPD; exercise training; pulmonary rehabilitation; antioxidant; muscle

Outcome Measures

Primary Outcomes (1)

• 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.

  up to day 37

Secondary Outcomes (2)

• muscle and /or serum oxidative stress level

  up to day 37

• Isometric maximal voluntary contraction of the quadriceps

  up to day 37

Study Arms (2)

Antioxidant Supplementation

ACTIVE COMPARATOR

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

Dietary Supplement: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program

Interventions

Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program DIETARY_SUPPLEMENT

Vit E, Vit C, Selenomethionine, Zinc gluconate

Antioxidant Supplementation; Placebo

Eligibility Criteria

• Age: 40 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• 5 Santé: collaborator

Study Sites (2)

Clinique du souffle la vallonie

Lodève, 34700, France

Location

University Hospital of Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 31178967 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: September 16, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

FR (2)