Pulmonary Disease, Chronic ObstructiveNCT00658853
Effective High Aerobic Intensity Endurance Training Regimes in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing 4 times 4 minutes high aerobic intensity one leg cycling in people with Pulmonary Disease, Chronic Obstructive and Hyperoxia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hyperoxia
- What is being tested?
- 4 times 4 minutes high aerobic intensity one leg cycling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Feb 2006
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD
Who cannot join
- Heart disease
- Walking or cycling inabilities
- Other diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effective High Aerobic Intensity Interval Training to Improve Maximal Oxygen Uptake in COPD Patients
4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hyperoxia
- Being tested
- 4 times 4 minutes high aerobic intensity one leg cycling
- Keywords
- COPD, training, VO2peak, performance, ventilation, high aerobic intensity treadmill walking, one leg training by cycling
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hyperoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 times 4 minutes high aerobic intensity one leg cyclingBehavioural
3 times per week for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | High aerobic intensity treadmill walking. 4 by 4 minutes interval training on a 5% graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. Receives: Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling |
| 2 | Active comparator | 4 times 4 minutes interval training in hyperoxia - 100% oxygen Receives: Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling |
| 3 | Active comparator | One leg at a time training 4 times 4 minutes interval training using cycling ergometer Receives: Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Measured: 10 weeks
Ventilation
Measured: 10 weeks
FEV1
Measured: 10 weeks
Walking performance
Measured: 10 weeks
Secondary outcomes (2)
Quality of life
Measured: 3 months
SPSS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startJan 2004
- Primary completionFeb 2006
- Study completionFeb 2006
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 Pulmonary Disease, Chronic ObstructiveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Helgerud, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658853
- Sponsor's protocol ID
- 149-03
- Status last verified
- Jul 2016
- First submitted
- 10 Apr 2008
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjorgen S, Helgerud J, Husby V, Steinshamn S, Richadson RR, Hoff J. Aerobic high intensity one-legged interval cycling improves peak oxygen uptake in chronic obstructive pulmonary disease patients; no additional effect from hyperoxia. Int J Sports Med. 2009 Dec;30(12):872-8. doi: 10.1055/s-0029-1238292.
PubMed 19821224
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective High Aerobic Intensity Interval Training to Improve Maximal Oxygen Uptake in COPD Patients
- ClinicalTrials.gov ID
- NCT00658853
- Acronym / sponsor ID
- 149-03
- Conditions
- Pulmonary Disease, Chronic Obstructive, Hyperoxia
- Keywords
- COPD, training, VO2peak, performance, ventilation, high aerobic intensity treadmill walking, one leg training by cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 15 Apr 2008 (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.
4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: 4 times 4 minutes high aerobic intensity one leg cyclingHigh aerobic intensity treadmill walking. 4 by 4 minutes interval training on a 5% graded treadmill at a heart rate corresponding to 85-95% of maximal heart rate. 3 times per week for 10 weeks. |
| 2 | Active comparator | Behavioral: 4 times 4 minutes high aerobic intensity one leg cycling4 times 4 minutes interval training in hyperoxia - 100% oxygen |
| 3 | Active comparator | Behavioral: 4 times 4 minutes high aerobic intensity one leg cyclingOne leg at a time training 4 times 4 minutes interval training using cycling ergometer |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD
Key exclusion criteria (3 listed)
- Heart disease
- Walking or cycling inabilities
- Other diseases
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 |
|---|---|---|
| 4 times 4 minutes high aerobic intensity one leg cycling3 times per week for 10 weeks | Behavioural | 1, 2, 3 |
Primary outcome
VO2peak
Time frame: 10 weeks
Ventilation
Time frame: 10 weeks
FEV1
Time frame: 10 weeks
Walking performance
Time frame: 10 weeks
2 secondary outcomes
Quality of life
Time frame: 3 months
SPSS
Time frame: 3 months
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 18 Jul 2016.
- Results publication: PubMed 19821224Bjorgen S, Helgerud J, Husby V, Steinshamn S, Richadson RR, Hoff J. Aerobic high intensity one-legged interval cycling improves peak oxygen uptake in chronic obstructive pulmonary disease patients; no additional effect from hyperoxia. Int J Sports Med. 2009 Dec;30(12):872-8. doi: 10.1055/s-0029-1238292.
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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.
Jan Helgerud, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 times 4 minutes high aerobic intensity one leg cycling in people with Pulmonary Disease, Chronic Obstructive and Hyperoxia, 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 3 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 18 Jul 2016. 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?
VO2peak (time frame: 10 weeks). The study lists 4 primary outcomes in all. 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 NCT00658853, 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 18 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.