Physical Function in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring Pulmonary rehabilitation, Exercise, Field walk test, Physical performance test
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) <0.7 and FEV1<80% of predicted value.
- Able to walk corridor and stairs
- Norwegian speaking
Exclusion Criteria:
- COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
- Not safe to exercise (e.g unstable angina)
- mental illness and drug abuse that makes group treatment not suitable
Sites / Locations
- Bente FriskRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulmonary rehabilitation
Arm Description
Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study.
Outcomes
Primary Outcome Measures
6-minute walk test
Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome
Secondary Outcome Measures
Incremental Shuttle walk test
Change from baseline to 6 weeks in walk distance in meter is the outcome
Endurance shuttle walk test
Change from baseline to 6 weeks in time in second is the outcome
30 second sit to stand test
Change from baseline to in number of repetition is the outcome
Stair test
Change from baseline to 6 weeks in time of the test is the outcome: 18 steps are walked up and down three times as fast as possible. Time in sec. is measured.
Full Information
NCT ID
NCT04107831
First Posted
September 15, 2019
Last Updated
September 26, 2019
Sponsor
Haukeland University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, Western Norway University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04107831
Brief Title
Physical Function in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Physical Function in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy, Western Norway University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aims of the study are to examine the responsiveness of, and the correlation between field walk tests and physical performance test in patients with chronic obstructive pulmonary disease (COPD) after participating in pulmonary rehabilitation.
Detailed Description
Patients with COPD who are participating at pulmonary rehabilitation (PR) at Haukeland University Hospital will be asked and consecutive enrolled to the study. Before and after PR the six-minute walk test, incremental- and endurance shuttle walk test, 30 sec sit-to-stand test and stair test will be used to evaluate change in physical capacity and -performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Pulmonary rehabilitation, Exercise, Field walk test, Physical performance test
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary rehabilitation
Arm Type
Experimental
Arm Description
Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study.
Intervention Type
Other
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Pre-post test design
Primary Outcome Measure Information:
Title
6-minute walk test
Description
Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome
Time Frame
up to 6 weeks
Secondary Outcome Measure Information:
Title
Incremental Shuttle walk test
Description
Change from baseline to 6 weeks in walk distance in meter is the outcome
Time Frame
up to 6 weeks
Title
Endurance shuttle walk test
Description
Change from baseline to 6 weeks in time in second is the outcome
Time Frame
up to 6 weeks
Title
30 second sit to stand test
Description
Change from baseline to in number of repetition is the outcome
Time Frame
up to 6 weeks
Title
Stair test
Description
Change from baseline to 6 weeks in time of the test is the outcome: 18 steps are walked up and down three times as fast as possible. Time in sec. is measured.
Time Frame
Up to 6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with COPD, Forced expiratory volume in 1 sec (FEV1)/Forced vital capacity (FVC) <0.7 and FEV1<80% of predicted value.
Able to walk corridor and stairs
Norwegian speaking
Exclusion Criteria:
COPD exacerbations requiring medical treatment last 4 weeks prior to inclusion led to deferment of inclusion
Not safe to exercise (e.g unstable angina)
mental illness and drug abuse that makes group treatment not suitable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bente Frisk, PhD
Phone
+4797003111
Email
bente.frisk@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Liv H. Magnussen, PhD
Phone
+4741108784
Email
liv.heide.magnussen@hvl.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Else Sterndorff, Director
Organizational Affiliation
Haukeland University Hospital, Dept. of Physiotherapy
Official's Role
Study Director
Facility Information:
Facility Name
Bente Frisk
City
Sandsli
ZIP/Postal Code
5253
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bente Frisk, PhD
Phone
+4797003111
Email
bente.frisk@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Liv H. Magnussen, PhD
Phone
+4741108784
Email
liv.heide.magnussen@hvl.no
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Physical Function in Patients With Chronic Obstructive Pulmonary Disease
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