NCT01077102

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

February 25, 2010

Last Update Submit

August 23, 2018

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysema

Keywords

COPDeccentric exercise trainingcycle ergometermuscle function

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    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 Outcomes (5)

  • Muscle cellular adaptation

    At baseline and at the end of the training program

  • Exercise capacity (maximal and submaximal)

    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

    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)

    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

    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

Study Arms (2)

Eccentric exercise training

EXPERIMENTAL
Other: Eccentric exercise training

Concentric exercise training

ACTIVE COMPARATOR
Other: Eccentric exercise training

Interventions

Eccentric exercise trainingOTHER

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.

Concentric exercise trainingEccentric exercise training

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Chest Institute

Montreal, Quebec, H2X 2P4, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysema

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jean Bourbeau

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

CA(1)