COPDNCT00908765
Effects of Aerobe Interval Training and Moderate Continuous Training in Chronic Obstructive Pulmonary Disease Patients
A study testing Exercise in people with COPD and Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2008to Sep 2009
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD with FEV1 25-60 % of exp , FEV1%FVC<70 %. Age 45-80 years
Who cannot join
- Heart failure
- symptomatic coronary artery disease
- cancer
- alcohol and drug abuse
- severe mental illness
- Lower respiratory infection last 4 weeks
- participation in exercise- or lung rehabilitation program last 3 months.
- oral steroid use
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Circulation and Medical Imaging , NTNU
Trondheim, Trondheim, 7089
About this study
Official title: Effects of Aerobe Interval Training and Moderate Continuous Training in COPD Patients
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. The investigators want to study the physiological response to two different training programs (High intensity aerobe interval training and moderate continuous aerobe training)with special focus on cardiac and skeletal muscle adaptions
Read the detailed description
Reduced exercise tolerance is one of the hallmarks of COPD and 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 contributes to this impairment . 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. It is still uncertain what type of endurance training that is most favourable for COPD patients.
In patients with heart failure and metabolic syndrome aerobe interval exercise have be shown to be superior in improving aerobic capacity and cardiac function
We therefore want conduct a study comparing training effects in patients with moderate to severe COPD, that participated in an identical training program that in HF and metabolic syndrome patients gave significant improvement in aerobic capacity, cardiac function and skeletal muscle function.
Patients will therefore be assigned to either 4x4 minutes high intensity interval treadmill exercise or continuous moderate intensity treadmill exercise 3 times pr week for 12 weeks. Aerobic capacity and work economy, pulmonary,cardiac and skeletal muscle function before and after the exercise training will be measured.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- Exercise
- Keywords
- Exercise Training COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called non
- High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks.
- Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aerobe Interval Training | Active comparator | High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. Receives: Behavioral: Exercise |
| Moderate Continous Training | Active comparator | Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2-peak
Measured: At inclusion and after 12 weeks of exercise training
Secondary outcomes (2)
Cardiac function
Measured: At inclusion and after 12 weeks of exercise training
Skeletal muscle function
Measured: At inclusion and after 12 weeks of exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionSep 2009
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 COPDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigurd Steinshamn, MD PhD, Principal investigator, NTNU , TrondheimEivind Brønstad, MD, Principal investigator, NTNU, Trondheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908765
- Sponsor's protocol ID
- 42008754
- Status last verified
- Jan 2013
- First submitted
- 20 Apr 2009
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bronstad E, Tjonna AE, Rognmo O, Dalen H, Heggli AM, Wisloff U, Ingul CB, Steinshamn S. Aerobic exercise training improves right- and left ventricular systolic function in patients with COPD. COPD. 2013 Jun;10(3):300-6. doi: 10.3109/15412555.2012.745843. Epub 2012 Dec 28.
PubMed 23272664
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobe Interval Training and Moderate Continuous Training in COPD Patients
- ClinicalTrials.gov ID
- NCT00908765
- Acronym / sponsor ID
- 42008754
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- Exercise Training COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 May 2009 (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.
Reduced exercise tolerance is one of the hallmarks of COPD. The principal causes for exercise intolerance are ventilatory limitation leading to deconditioning and inactivity. So far it is poorly understood which form of exercise is the most effective in training this condition. The investigators want to study the physiological response to two different training programs (High intensity aerobe interval training and moderate continuous aerobe training)with special focus on cardiac and skeletal muscle adaptions
Detailed description
Reduced exercise tolerance is one of the hallmarks of COPD and 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 contributes to this impairment . 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. It is still uncertain what type of endurance training that is most favourable for COPD patients.
In patients with heart failure and metabolic syndrome aerobe interval exercise have be shown to be superior in improving aerobic capacity and cardiac function
We therefore want conduct a study comparing training effects in patients with moderate to severe COPD, that participated in an identical training program that in HF and metabolic syndrome patients gave significant improvement in aerobic capacity, cardiac function and skeletal muscle function.
Patients will therefore be assigned to either 4x4 minutes high intensity interval treadmill exercise or continuous moderate intensity treadmill exercise 3 times pr week for 12 weeks. Aerobic capacity and work economy, pulmonary,cardiac and skeletal muscle function before and after the exercise training will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobe Interval Training | Active comparator | Behavioral: ExerciseHigh aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. |
| Moderate Continous Training | Active comparator | Behavioral: ExerciseModerate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD with FEV1 25-60 % of exp , FEV1%FVC<70 %. Age 45-80 years
Key exclusion criteria (8 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 |
|---|---|---|
| ExerciseAlso: non1. High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. 2. Moderate continuous intensity treadmill walking on a graded treadmill at a heart rate corresponding to 60-70 of maximal heart rate, 3 times per week for 10 weeks | Behavioural | Aerobe Interval Training, Moderate Continous Training |
Primary outcome
VO2-peak
Time frame: At inclusion and after 12 weeks of exercise training
2 secondary outcomes
Cardiac function
Time frame: At inclusion and after 12 weeks of exercise training
Skeletal muscle function
Time frame: At inclusion and after 12 weeks of exercise 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 3 Jan 2013.
- Results publication: PubMed 23272664Bronstad E, Tjonna AE, Rognmo O, Dalen H, Heggli AM, Wisloff U, Ingul CB, Steinshamn S. Aerobic exercise training improves right- and left ventricular systolic function in patients with COPD. COPD. 2013 Jun;10(3):300-6. doi: 10.3109/15412555.2012.745843. Epub 2012 Dec 28.
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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.
Sigurd Steinshamn, MD PhD principal investigator
NTNU , Trondheim
Eivind Brønstad, MD principal investigator
NTNU, Trondheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with COPD and Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 8 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 3 Jan 2013. 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 Norway. 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?
VO2-peak (time frame: At inclusion and after 12 weeks of exercise 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 NCT00908765, 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 3 Jan 2013.