Physical Function in Patients With Chronic Obstructive Pulmonary Disease

January 4, 2024 updated by: Haukeland University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Norway
      • Sandsli, Norway, 5253
        • Bente Frisk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary rehabilitation
Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study.
Other: Pulmonary rehabilitation
Pre-post test design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: up to 6 weeks
Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome
up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental Shuttle walk test
Time Frame: up to 6 weeks
Change from baseline to 6 weeks in walk distance in meter is the outcome
up to 6 weeks
Endurance shuttle walk test
Time Frame: up to 6 weeks
Change from baseline to 6 weeks in time in second is the outcome
up to 6 weeks
30 second sit to stand test
Time Frame: up to 6 weeks
Change from baseline to in number of repetition is the outcome
up to 6 weeks
Stair test
Time Frame: Up to 6 weeks
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.
Up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Collaborators

Western Norway University of Applied Sciences
Norwegian Fund for Postgraduate Training in Physiotherapy

Investigators

  • Study Director: Else Sterndorff, Director, Haukeland University Hospital, Dept. of Physiotherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 15, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HaukelandUH- 2019/852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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