Trial record 6 of 28 for:    Open Studies | "Bronchitis, Chronic"

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
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic
Emphysema
Other: Eccentric exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eccentric Training as Novel Rehabilitation for COPD

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 14
Study Start Date: February 2010
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eccentric exercise training 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.
Active Comparator: Concentric exercise training 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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077102

Contacts
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

Locations
Canada, Quebec
Montreal Chest Institute Recruiting
Montreal, Quebec, Canada, H2X 2P4
Contact: Jacinthe Barril, Ph.D.    514-934-1934 ext 32154    jacinthe.baril@mail.mcgill.ca   
Sponsors and Collaborators
McGill University
McGill University Health Center
Investigators
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
  More Information

No publications provided

Responsible Party: Jean Bourbeau MD, M.Sc., Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01077102     History of Changes
Other Study ID Numbers: MUHC Pilot Project 2007
Study First Received: February 25, 2010
Last Updated: February 25, 2010
Health Authority: Canada: Health Canada

Keywords provided by McGill University:
COPD
eccentric exercise training
cycle ergometer
muscle function

Additional relevant MeSH terms:
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Bronchitis
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 30, 2014