Pulmonary Disease, Chronic ObstructiveNCT01077102
Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD)
A study testing Eccentric exercise training in people with Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
- What is being tested?
- Eccentric exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Eccentric exercise training
- Keywords
- COPD, eccentric exercise training, cycle ergometer, muscle function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric exercise training | Experimental | Not described Receives: Other: Eccentric exercise training |
| Concentric exercise training | Active comparator | Not described Receives: Other: Eccentric exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
This outcome will be measured using an isokinetic dynamometer
Measured: 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
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)
Measured: At baseline and at the end of the training program
Exercise capacity (maximal and submaximal)
Measured: 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
Physical activity levels will be measured by an accelerometer and by the CHAMPS questionnaire.
Measured: 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)
The HRQL will be measured by the Chronic Respiratory Questionnaire
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jean Bourbeau, M.D, M.Sc., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreTanja Taivassalo, Ph.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreHelene Perrault, Ph.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077102
- Sponsor's protocol ID
- MUHC Pilot Project 2007
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2010
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Training as Novel Rehabilitation for COPD
- ClinicalTrials.gov ID
- NCT01077102
- Acronym / sponsor ID
- MUHC Pilot Project 2007
- Keywords
- COPD, eccentric exercise training, cycle ergometer, muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise training | Experimental | Other: Eccentric exercise training |
| Concentric exercise training | Active comparator | Other: Eccentric exercise training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eccentric exercise trainingThe 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. | Other | Concentric exercise training, Eccentric exercise training |
Primary outcome
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
5 secondary outcomes
Muscle cellular adaptation
Time frame: 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Bourbeau, M.D, M.Sc. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Tanja Taivassalo, Ph.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Helene Perrault, Ph.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise training in people with Pulmonary Disease, Chronic Obstructive and Bronchitis, Chronic, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 10-wk training program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.