Intervention Study to Investigate Supplemental Oxygen in COPD

  • STATUS
    Recruiting
  • End date
    Dec 8, 2023
  • participants needed
    144
  • sponsor
    Uppsala University
Updated on 8 July 2022
bronchodilator
forced expiratory volume
walk tests

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.

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.

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.

Details
Condition COPD, Physical Activity, Sedentary
Treatment Supplemental oxygen
Clinical Study IdentifierNCT01783808
SponsorUppsala University
Last Modified on8 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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