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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
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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

Learn more about this trial

Physical Function in Patients With Chronic Obstructive Pulmonary Disease

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