Intervention Study to Investigate Supplemental Oxygen in COPD
NCT ID: NCT01783808
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
144 participants
INTERVENTIONAL
2012-11-30
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases
NCT06385301
Acute Effects of Supramaximal High-Intensity Interval Training in People With COPD
NCT05874999
Effect of Short-term Oxygen During CPET in COPD
NCT03196089
Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise
NCT00592033
Aerobic Interval Training in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypoxemia
NCT03092622
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Supplemental oxygen
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.
Supplemental oxygen
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.
Control group
The control group will not get supplemental oxygen during physical activity but they will get the same physical activity intervention as the intervention group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supplemental oxygen
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Umeå University
OTHER
Karolinska Institutet
OTHER
University of California, Los Angeles
OTHER
Uppsala University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Margareta Emtner
PhD, Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christer Janson, Professor
Role: STUDY_CHAIR
Department of Medical Sciences, Uppsala University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Akademiska sjukhuset
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Uppsala University
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Ambox-2012-MEUP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.