Intervention Study to Investigate Supplemental Oxygen in COPD

COPD Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01783808
• Other study ID #: Ambox-2012-MEUP
• Secondary ID: Uppsala Universi
• Status: Recruiting
• Phase: N/A
• Start date: November 2012
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: Uppsala University
• Contact: Margareta I Emtner, PhD
• Phone: +46184714761
• Email: margareta.emtner[@]neuro.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Physical Activity
• Sedentary

Intervention

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.

Locations

Country	Name	City	State
Sweden	Akademiska sjukhuset	Uppsala

Sponsors (4)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet, Umeå University, University of California, Los Angeles

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related quality of life	EuroQol five-dimension questionnaire, St Georges Respiratory Questionnaire, Hospital Anxiety and Depression Scale, COPD Assessment Test, Medical Research Council scale	Change from baseline to six months
Other	Inflammatory markers	C-reactive protein, Leucocytes, Thrombocytes, Erythrocytes, Hemoglobin	Change from baseline to 6 months
Primary	Six-minute walk test	The patient is supposed to walk as long as possible during six minutes.	Change from baseline to 6 months
Secondary	Physical activity level	Physical activity will be measured with an activity monitor (accelerometer) and by a questionnaire	Change from baseline to 6 months