Chronic Obstructive Pulmonary DiseaseNCT01079221
Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing High intensity knee-extensor training in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology.
Trial summary
COPD patients have a reduced exercise tolerance due to a ventilatory limitation. Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High intensity knee-extensor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis with FEV1<70% exp, FEV1%FVC <70 %
- Age> 50 years
Who cannot join
- Heart failure
- Symptomatic coronary artery disease
- Cancer
- Alcohol and drug abuse
- Severe mental illness
- Lower respiratory illness
Show all 9Show fewer
- Participation in exercise- or lung rehabilitation program last 3 months
- pregnancy
- oral steroid use
About this study
COPD patients have a reduced exercise tolerance due to a ventilatory limitation.
Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients.
Read the detailed description
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contribute to this impairment as well. Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction.
Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation.
In this study we investigate training effects in patients with moderate to severe COPD with special focus on skeletal muscle.
COPD patients will perform high intensity aerobic interval knee-extensor exercise training 3 days/week for six weeks . At baseline and follow-up, muscle oxygen consumption and mitochondrial respiration will be measured.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High intensity knee-extensor training
- Keywords
- exercise, Knee extensor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity knee-extensor trainingBehavioural
High intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Knee extensor exercise training | Experimental | High intensity aerobic knee-extensor exercise training Receives: Behavioral: High intensity knee-extensor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak power
Measured: At inclusion and after 6 weeks of training
Secondary outcomes (1)
Mitochondrial respiration, Vmax
Measured: At inclusion and after 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, PhD prof., Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079221
- Sponsor's protocol ID
- 42009297
- Status last verified
- Aug 2016
- First submitted
- 2 Mar 2010
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bronstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Haberg AK, Ingul CB, Wisloff U, Steinshamn S. High-intensity knee extensor training restores skeletal muscle function in COPD patients. Eur Respir J. 2012 Nov;40(5):1130-6. doi: 10.1183/09031936.00193411. Epub 2012 Mar 9.
PubMed 22408206
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Knee-extensor Exercise Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT01079221
- Acronym / sponsor ID
- 42009297
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- exercise, Knee extensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Mar 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.
COPD patients have a reduced exercise tolerance due to a ventilatory limitation.
Several studies have shown altered skeletal muscle function. The investigator will study the physiological response to knee-extensor exercise in COPD patients.
Detailed description
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. However the weak correlation between exercise capacity and FEV1 implies that other factors than reduced pulmonary function contribute to this impairment as well. Several studies have found changes in skeletal muscle, with fibre shift, increased oxidative stress, increased inflammatory cytokines and impaired mitochondrial function, suggesting a lower limb dysfunction.
Numerous exercise studies in COPD patients have shown physiological and physiological benefits of training and endurance training is now regarded as an important part in pulmonary rehabilitation.
In this study we investigate training effects in patients with moderate to severe COPD with special focus on skeletal muscle.
COPD patients will perform high intensity aerobic interval knee-extensor exercise training 3 days/week for six weeks . At baseline and follow-up, muscle oxygen consumption and mitochondrial respiration will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee extensor exercise training | Experimental | Behavioral: High intensity knee-extensor trainingHigh intensity aerobic knee-extensor exercise training |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD diagnosis with FEV1<70% exp, FEV1%FVC <70 %
- Age> 50 years
Key exclusion criteria (9 listed)
- Heart failure
- Symptomatic coronary artery disease
- Cancer
- Alcohol and drug abuse
- Severe mental illness
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 |
|---|---|---|
| High intensity knee-extensor trainingHigh intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks | Behavioural | Knee extensor exercise training |
Primary outcome
Peak power
Time frame: At inclusion and after 6 weeks of training
1 secondary outcome
Mitochondrial respiration, Vmax
Time frame: At inclusion and after 6 weeks 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 2 Aug 2016.
- Results publication: PubMed 22408206Bronstad E, Rognmo O, Tjonna AE, Dedichen HH, Kirkeby-Garstad I, Haberg AK, Ingul CB, Wisloff U, Steinshamn S. High-intensity knee extensor training restores skeletal muscle function in COPD patients. Eur Respir J. 2012 Nov;40(5):1130-6. doi: 10.1183/09031936.00193411. Epub 2012 Mar 9.
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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.
Ulrik Wisløff, PhD prof. study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing High intensity knee-extensor training in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology.
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 2 inclusion and 9 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak power (time frame: At inclusion and after 6 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079221, which also lists 1 linked publication.
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 2 Aug 2016.