COPDNCT01783808
Intervention Study to Investigate Supplemental Oxygen in COPD
A study testing Supplemental oxygen in people with COPD and Physical Activity, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Physical Activity, Sedentary
- What is being tested?
- Supplemental oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2012to Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD, Arterial Oxygen Saturation > 8 kilopascal at rest
- Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
- No exacerbation within 4 weeks prior to the study
- Post-bronchodilator forced expiratory volume at one second < 80% predicted and forced expiratory volume at one second /Vital capacity < 0.7
- Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
- Non-smoker (smoke free for ≥ 6 months)
- Interest in being physically active
Who cannot join
- Arterial carbon dioxide > 6.5 kilopascal at rest
- Orthopedic, neurologic or mental impairments that would limit physical activity
- Neoplastic disease that is anticipated to influence survival
- Patients exercising with supplemental oxygen
- Long-term oxygen therapy
- Patients with arterial auricular fibrillation and/or heart disease that might hinder physical activity as judged by the physician
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Akademiska sjukhuset
Uppsala, 751 85
Margareta I Emtner, PhD, +46184714761, margareta.emtner@neuro.uu.se
Christer Janson, Professor, +46186114115, christer.janson@medsci.uu.se
About this study
Official title: Effects on Exercise Capacity, Physical Activity and Quality of Life Using Ambulatory Oxygen in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Desaturate Only During Exercise
The purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test.
Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.
Read the detailed description
Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity.
The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.
- Conditions
- COPD, Physical Activity, Sedentary
- Being tested
- Supplemental oxygen
- Keywords
- COPD, Physical capacity, Physical activity, Inflammatory markers, Health related quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygenOther
Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months.
In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used.
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Experimental | Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months.
In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used. Receives: Other: Supplemental oxygen |
| Control group | No intervention | The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
The patient is supposed to walk as long as possible during six minutes.
Measured: Change from baseline to 6 months
Secondary outcomes (1)
Physical activity level
Physical activity will be measured with an activity monitor (accelerometer) and by a questionnaire
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University, Karolinska Institutet, University of California, Los Angeles
- Responsible party
- Principal investigator, Margareta Emtner, Uppsala University
- Investigators
- Christer Janson, Professor, Study chair, Department of Medical Sciences, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783808
- Sponsor's protocol ID
- Ambox-2012-MEUP
- Other IDs
- Uppsala University
- Status last verified
- Jun 2022
- First submitted
- 16 Jan 2013
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Exercise Capacity, Physical Activity and Quality of Life Using Ambulatory Oxygen in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Desaturate Only During Exercise
- ClinicalTrials.gov ID
- NCT01783808
- Acronym / sponsor ID
- Ambox-2012-MEUP
- Conditions
- COPD, Physical Activity, Sedentary
- Keywords
- COPD, Physical capacity, Physical activity, Inflammatory markers, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Umeå University, Karolinska Institutet, University of California, Los Angeles
- Study start
- Nov 2012 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Feb 2013 (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 purpose of this trial is to study the effects on exercise capacity, physical activity, inflammatory markers and quality of life of supplemental ambulatory oxygen, to be used during physical activity, in patients with COPD who are normoxic at rest but hypoxemic during a six-min walk test.
Our hypothesis is that if patients are able to use supplemental oxygen they will be more physically active and thereby improve health related quality of life.
Detailed description
Study design The study will employ a parallel design for 6 months including 144 patients (72 patients/group). Patients will be randomized to intervention or control group. The intervention comprises supplemental oxygen to be used during physical activity for 6 months. The control group will receive the same physical activity instructions as the intervention group during the 6 months, but they will not be able to use supplemental oxygen during physical activity.
The study will be a prospective, randomized, single-blind multi-centre intervention study with an intention to treat design (last value carry over). Inclusion will continue until 144 patients have fulfilled the 6 months. Patients will be tested at baseline and after 6 months. There will also be a follow-up after 12 months comprising questionnaires. The study will include centers in Sweden Norway, Finland, and Estonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supplemental oxygen | Experimental | Other: Supplemental oxygenPatients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months. In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used. |
| Control group | No intervention | –The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- COPD, Arterial Oxygen Saturation > 8 kilopascal at rest
- Oxygen Saturation ≤ 88% and a fall in Oxygen Saturation ≥ 4% during a six-minute walk test in ambient air
- No exacerbation within 4 weeks prior to the study
- Post-bronchodilator forced expiratory volume at one second < 80% predicted and forced expiratory volume at one second /Vital capacity < 0.7
- Oxygen Saturation ≥ 92 % during a walk test in self-selected pace with supplemental oxygen. Patients should use supplemental oxygen 10 minutes before the test starts.
Key exclusion criteria (6 listed)
- Arterial carbon dioxide > 6.5 kilopascal at rest
- Orthopedic, neurologic or mental impairments that would limit physical activity
- Neoplastic disease that is anticipated to influence survival
- Patients exercising with supplemental oxygen
- Long-term oxygen therapy
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 |
|---|---|---|
| Supplemental oxygenPatients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months. In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used. | Other | Supplemental oxygen |
Primary outcome
Six-minute walk test
Time frame: Change from baseline to 6 months
The patient is supposed to walk as long as possible during six minutes.
1 secondary outcome
Physical activity level
Time frame: Change from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
Christer Janson, Professor study chair
Department of Medical Sciences, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental oxygen in people with COPD and Physical Activity, run by Uppsala University at 1 site in Sweden.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margareta I Emtner, PhD (+46184714761, margareta.emtner@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (time frame: Change from baseline to 6 months). 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 21 Jun 2022.