Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD)

Eccentric Training as Novel Rehabilitation for COPD

The main purpose of this project is to establish the additional value of eccentric versus concentric exercise to optimize muscle function in patients with severe COPD. With this pilot project the investigators expect that an eccentric endurance training protocol adapted to severe COPD patients will lead to gains in muscle strength, the primary outcome, and cellular adaptation (muscle morphology and oxidative capacity, mitochondrial respiratory capacity) when compared to a concentric training approach.

This information will be essential if the investigators want to design and power a randomized clinical trial that will allow assessing effectiveness of this novel rehabilitation approach.

Study Overview

Detailed Description

Chronic obstructive pulmonary disease (COPD) is a major respiratory illness that is both preventable and treatable. Dyspnea is the most important symptom that COPD patients experience and this can have a major impact on their daily live. While COPD is characterized by a spectrum of disease severity, most patients experience poor exercise intolerance attributable to ventilatory limitation as well as peripheral muscle fatigue, ultimately leading to severe disability.

Endurance exercise is an important component of pulmonary rehabilitation and is aimed at preventing this decline in functional capacity. The effects of pulmonary rehabilitation are largely attributable to the exercise training component involving concentric muscle contractions, traditionally trough dynamic, large muscle exercise on a cycle ergometer or treadmill. However, many patients are unable to partake and benefit from such rehabilitation because of locomotor muscle weakness and severe ventilatory limitation that prevent them from exercising at intensities sufficient to provoke improvements in cardioventilatory and skeletal muscle function. Eccentric exercise is known for its unique physiologically fundamental characteristics: the lower metabolic demand for a same power output and greater muscle gains compared to the concentric exercise. For this reason, eccentric endurance training has been proposed as a novel adjunctive rehabilitative countermeasure for certain chronic diseases (such as coronary disease and COPD) and can play an important role for patients with advanced disease.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H2X 2P4
        • Montreal Chest Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male patients with severe COPD (FEV1/FVC < 0.70 and FEV1 ≤ 50% predicted of normal)
  • Patients aged 40 to 80 years old in whom exercise is not contraindicated
  • Current and ex-smokers
  • Patients who do not require oxygen therapy

Exclusion Criteria:

  • Patients presenting neurological or orthopedic problems, morbid obesity, acute medical condition or recent exacerbations (in the last four weeks)
  • Patients with recent or current participation in a rehabilitation program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eccentric exercise training
The eccentric exercise training will be performed using a specially built cycle ergo meter where the pedals are driven in backward direction by an electric motor, which has to overcome the adjustable resistance of the electromagnetic brake. During eccentric cycle ergometry patients have to resist the turning pedals.
Active Comparator: Concentric exercise training
The eccentric exercise training will be performed using a specially built cycle ergo meter where the pedals are driven in backward direction by an electric motor, which has to overcome the adjustable resistance of the electromagnetic brake. During eccentric cycle ergometry patients have to resist the turning pedals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
This outcome will be measured using an isokinetic dynamometer
At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle cellular adaptation
Time Frame: At baseline and at the end of the training program
Muscle biopsy will include evaluation of cross-sectional area, fiber type, mitochondrial oxidative capacity, mitochondrial respiratory capacity, respiratory oxygen species and expression of genes involved in muscle atrophy and hypertrophy (Atrogin-1, MurF1, FoxO, MyoD, Myostatin)
At baseline and at the end of the training program
Exercise capacity (maximal and submaximal)
Time Frame: At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
Physical Activity
Time Frame: At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
Physical activity levels will be measured by an accelerometer and by the CHAMPS questionnaire.
At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
Health-related quality of life (HRQL)
Time Frame: At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
The HRQL will be measured by the Chronic Respiratory Questionnaire
At baseline, at the middle way point of the training program (5th to 7th week) and at the end of the 10-wk training program
Muscle pain and creatine kinase(CK)levels
Time Frame: Muslce pain will be assessed in the beginning and in the end of each session and CK levels at baseline, after the fisrt week of training, midway through and the after the last week of training
Muslce pain will be assessed in the beginning and in the end of each session and CK levels at baseline, after the fisrt week of training, midway through and the after the last week of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean Bourbeau, M.D, M.Sc., McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Tanja Taivassalo, Ph.D., McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Helene Perrault, Ph.D., McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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