NCT04107831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 15, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 5, 2024

Status Verified

March 1, 2023

Enrollment Period

5.4 years

First QC Date

September 15, 2019

Last Update Submit

January 4, 2024

Conditions

COPD

Keywords

Pulmonary rehabilitationExerciseField walk testPhysical performance test

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test

    Change from baseline to 6 weeks in 6 minute walk distance in meter is primary outcome

    up to 6 weeks

Secondary Outcomes (4)

  • Incremental Shuttle walk test

    up to 6 weeks

  • Endurance shuttle walk test

    up to 6 weeks

  • 30 second sit to stand test

    up to 6 weeks

  • Stair test

    Up to 6 weeks

Study Arms (1)

Pulmonary rehabilitation

EXPERIMENTAL

Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study.

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationOTHER

Pre-post test design

Pulmonary rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not safe to exercise (e.g unstable angina)
  • mental illness and drug abuse that makes group treatment not suitable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bente Frisk

Sandsli, 5253, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Else Sterndorff, Director

    Haukeland University Hospital, Dept. of Physiotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 27, 2019

Study Start

August 9, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 5, 2024

Record last verified: 2023-03

Locations

NO(1)