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Intervention Study to Investigate Supplemental Oxygen in COPD

This study is currently recruiting participants.
Verified February 2013 by Uppsala University
Sponsor:
Collaborators:
Umeå University
Karolinska Institutet
University of California, Los Angeles
Information provided by (Responsible Party):
Margareta Emtner, Uppsala University
ClinicalTrials.gov Identifier:
NCT01783808
First received: January 16, 2013
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
COPD
Physical Activity
Sedentary
 Other: Supplemental oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Six-minute walk test [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    The patient is supposed to walk as long as possible during six minutes.


Secondary Outcome Measures:
  • Physical activity level [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    Physical activity will be measured with an activity monitor (accelerometer) and by a questionnaire


Other Outcome Measures:
  • Health related quality of life [ Time Frame: Change from baseline to six months ] [ Designated as safety issue: No ]
    EuroQol five-dimension questionnaire, St Georges Respiratory Questionnaire, Hospital Anxiety and Depression Scale, COPD Assessment Test, Medical Research Council scale

  • Inflammatory markers [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
    C-reactive protein, Leucocytes, Thrombocytes, Erythrocytes, Hemoglobin


Estimated Enrollment: 144
Study Start Date: November 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

 Other: 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.
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783808

Contacts
Contact: Margareta I Emtner, PhD +46184714761 margareta.emtner@neuro.uu.se
Contact: Karin Wadell, PhD +4690786 9887 karin.wadell@physiother.umu.se

Locations
Sweden
Akademiska sjukhuset Recruiting
Uppsala, Sweden, 751 85
Contact: Margareta I Emtner, PhD     +46184714761     margareta.emtner@neuro.uu.se    
Contact: Christer Janson, Professor     +46186114115     christer.janson@medsci.uu.se    
Principal Investigator: Margareta I Emtner, PhD            
Sponsors and Collaborators
Uppsala University
Umeå University
Karolinska Institutet
University of California, Los Angeles
Investigators
Study Chair: Christer Janson, Professor Department of Medical Sciences, Uppsala University
  More Information

No publications provided

Responsible Party: Margareta Emtner, PhD, Associate Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01783808     History of Changes
Other Study ID Numbers: Ambox-2012-MEUP, Uppsala University
Study First Received: January 16, 2013
Last Updated: February 1, 2013
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Uppsala University:
COPD
Physical capacity
Physical activity
Inflammatory markers
Health related quality of life

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013