Intervention Study to Investigate Supplemental Oxygen in COPD

NCT01783808 | Unknown

• 2 other identifiers: Ambox-2012-MEUPUppsala University
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Physical Activity; Sedentary

Keywords

COPD; Physical capacity; Physical activity; Inflammatory markers; Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Six-minute walk test

  The patient is supposed to walk as long as possible during six minutes.

  Change from baseline to 6 months

Secondary Outcomes (1)

• Physical activity level

  Change from baseline to 6 months

Other Outcomes (2)

• Health related quality of life

  Change from baseline to six months

• Inflammatory markers

  Change from baseline to 6 months

Study Arms (2)

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.

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.

Interventions

Supplemental oxygen OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Umeå University: collaborator
• Karolinska Institutet: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Akademiska sjukhuset

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Christer Janson, Professor

  Department of Medical Sciences, Uppsala University

  STUDY CHAIR

Central Study Contacts

Margareta I Emtner, PhD

CONTACT

+46184714761; margareta.emtner@neuro.uu.se

Karin Wadell, PhD

CONTACT

+4690786 9887; karin.wadell@physiother.umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: February 5, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

SE (1)