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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by McGill University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
McGill University Health Center
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT01077102
First received: February 25, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted

February 25, 2010
February 25, 2010
February 2010
September 2010   (final data collection date for primary outcome measure)
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 12-wk training program ] [ Designated as safety issue: No ]
This outcome will be measured using an isokinetic dynamometer
Same as current
No Changes Posted
  • Muscle cellular adaptation [ Time Frame: At baseline and at the end of the training program ] [ Designated as safety issue: No ]
    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)
  • 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 12-wk training program ] [ Designated as safety issue: No ]
  • 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 12-wk training program ] [ Designated as safety issue: No ]
    Physical activity levels will be measured by an accelerometer and by the CHAMPS questionnaire.
  • 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 12-wk training program ] [ Designated as safety issue: No ]
    The HRQL will be measured by the Chronic Respiratory Questionnaire
  • Muscle pain and creatine kinase(CK)levels [ Time Frame: Muslce pain will be assesed 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Bronchitis, Chronic
  • Emphysema
Other: Eccentric exercise training
The eccentric exercise training will be performed using a specially built cycle ergometer 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.
  • Experimental: Eccentric exercise training
    Intervention: Other: Eccentric exercise training
  • Active Comparator: Concentric exercise training
    Intervention: Other: Eccentric exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
November 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 14 male patients with severe COPD (FEV1/FVC < 0.70 and FEV1 ≤ 50% predicted of normal)
  • Patients aged 40 to 75 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
  • Patients who are currently taking Coumadin or Plavix
Male
40 Years to 75 Years
No
Contact: Jacinthe Baril, M.Sc. 514-934-1934 ext 32154 jacinthe.baril@mail.mcgill.ca
Contact: Jean Bourbeau, M.D., M.Sc. 514-934-1934 ext 32158 jean.bourbeau@mcgill.ca
Canada
 
NCT01077102
MUHC Pilot Project 2007
Yes
Jean Bourbeau MD, M.Sc., Research Institute of the McGill University Health Centre
McGill University
McGill University Health Center
Principal Investigator: Jean Bourbeau, M.D, M.Sc. McGill University Health Center
Principal Investigator: Tanja Taivassalo, Ph.D. McGill University Health Center
Principal Investigator: Helene Perrault, Ph.D. McGill University Health Center
McGill University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP