Back to resultsEffect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease, Hypoxia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- Chronic obstructive pulmonary disease
Exclusion Criteria:
- No exacerbation
- No active heart disease
Sites / Locations
- LHL-klinikkene Glittre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supplementary oxygen
Arm Description
Study subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag
Outcomes
Primary Outcome Measures
Pulmonary ventilation
Secondary Outcome Measures
Dyspnoea
Heart rate
Blood pressure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02108925
Brief Title
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
Official Title
Oxygen Supply and Ventilation During Physical Exercise in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LHL Helse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project will test the hypothesis that lung ventilation during exercise is unaffected by oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea, heart rate and blood pressure will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supplementary oxygen
Arm Type
Experimental
Arm Description
Study subjects receive, in randomized order, either supplementary 30% oxygen or air (21% Oxygen) from a gas tight bag
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
supplementary oxygen during exercise
Primary Outcome Measure Information:
Title
Pulmonary ventilation
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Dyspnoea
Time Frame
1 hour
Title
Heart rate
Time Frame
1 hour
Title
Blood pressure
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic obstructive pulmonary disease
Exclusion Criteria:
No exacerbation
No active heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Edvardsen, PhD
Organizational Affiliation
LHL Helse
Official's Role
Principal Investigator
Facility Information:
Facility Name
LHL-klinikkene Glittre
City
Hakadal
State/Province
Akershus
ZIP/Postal Code
1485
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
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