Pulmonary Disease, Chronic ObstructiveNCT03092622
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
A study testing Exercise in people with Pulmonary Disease, Chronic Obstructive and Hypertension, Pulmonary, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Hypoxia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2017to 31 Dec 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Obstructive Pulmonary Disease (COPD)
- Forced Expiratory Volume 1 second (FEV1) <60% of predicted
- FEV1%FVC <70 % of predicted (FVC = Forced Vital Capacity)
- Qualify for Long term oxygen therapy (LTOT), or presence of significant desaturation on exercise.
Who cannot join
- Unstable ischaemic heart disease or valvular heart disease.
- Active malignant disease.
- Substance abuse.
- Physical or mental disability that prevents participation in the exercise programme or testing.
- Pregnancy.
- Exacerbation of COPD or respiratory tract infection last 6 weeks before.
- Completed pulmonary rehabilitation programme or other organised exercise programme last 3 month
- Use of high doses of systemic steroids.
Trial locations and contacts
1 site in 1 country.
Norway1 site
St Olavs Hospital, Lungemedisinsk Avdeling & Hjertemedisinsk Avdeling
Trondheim
About this study
Official title: Effects of Aerobic Interval Training on Cardiac Function, With Special Focus on Pulmonary Pressures and Right Sided Function, in Patients With Chronic Obstructive Pulmonary Disease and Hypoxemia
Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise training in patients with severe COPD and concomitant low oxygen levels is beneficial.
This study aims to evaluate the effects of aerobic interval exercise training in patients with severe COPD and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.
- Being tested
- Exercise
- Keywords
- Exercise Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise training intervention as described earlier.
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Experimental | Outpatients treadmill interval training, 4x4 minutes with 3 minutes in between at lower intensity. 3 sessions weekly for 10 weeks to a total of 30 sessions. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery pressure
Examined by right heart catheterisation
Measured: Change from baseline at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Toril A Nagelhus Hernes, phd prof, Study chair, Norwegian University of Science and TechnologySigurd Steinshamn, md prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092622
- Sponsor's protocol ID
- 2013/2129
- Status last verified
- Jan 2020
- First submitted
- 22 Feb 2017
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Interval Training on Cardiac Function, With Special Focus on Pulmonary Pressures and Right Sided Function, in Patients With Chronic Obstructive Pulmonary Disease and Hypoxemia
- ClinicalTrials.gov ID
- NCT03092622
- Acronym / sponsor ID
- 2013/2129
- Keywords
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
Patients with severe Chronic Obstructive Pulmonary Disease (COPD) and low oxygen levels in the blood are at risk of developing pulmonary hypertension and strain on the right side of the heart, both of which are known to increase symptoms and worsen prognosis It is not fully established whether interval exercise training in patients with severe COPD and concomitant low oxygen levels is beneficial.
This study aims to evaluate the effects of aerobic interval exercise training in patients with severe COPD and low oxygen levels in the blood, with a particular emphasis on such effects on the cardiovascular system and pulmonary circulation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise training | Experimental | Other: ExerciseOutpatients treadmill interval training, 4x4 minutes with 3 minutes in between at lower intensity. 3 sessions weekly for 10 weeks to a total of 30 sessions. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic Obstructive Pulmonary Disease (COPD)
- Forced Expiratory Volume 1 second (FEV1) <60% of predicted
- FEV1%FVC <70 % of predicted (FVC = Forced Vital Capacity)
- Qualify for Long term oxygen therapy (LTOT), or presence of significant desaturation on exercise.
Key exclusion criteria (8 listed)
- Unstable ischaemic heart disease or valvular heart disease.
- Active malignant disease.
- Substance abuse.
- Physical or mental disability that prevents participation in the exercise programme or testing.
- Pregnancy.
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 |
|---|---|---|
| ExerciseExercise training intervention as described earlier. | Other | exercise training |
Primary outcome
Pulmonary artery pressure
Time frame: Change from baseline at 10 weeks
Examined by right heart catheterisation
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 30 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Toril A Nagelhus Hernes, phd prof study chair
Norwegian University of Science and Technology
Sigurd Steinshamn, md prof 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 Exercise in people with Pulmonary Disease, Chronic Obstructive and Hypertension, Pulmonary, 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 4 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 30 Jan 2020. 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?
Pulmonary artery pressure (time frame: Change from baseline at 10 weeks). 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 30 Jan 2020.