Physical Function in Patients With Chronic Obstructive Pu... | NCT04107831

Studies
Physical Function in Patients With Chronic Obstructive Pulmonary Disease

NCT04107831

Sponsor

Haukeland University Hospital

Status

Unknown status

Last Update Posted

Jan 5, 2024Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Pulmonary rehabilitation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 9, 2019Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 15, 2019

First Submission Date that Met QC Criteria

Sep 26, 2019

First Posted Date

Sep 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2024

Last Update Posted Date

Jan 5, 2024Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary rehabilitation	Experimental	Participants who are participating in a 6-week pulmonary rehabilitation program are enrolled in the study.	Other: Pulmonary rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation	Other	Pre-post test design	Pulmonary rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incremental Shuttle walk test	Change from baseline to 6 weeks in walk distance in meter is the outcome	up to 6 weeks
Endurance shuttle walk test	Change from baseline to 6 weeks in time in second is the outcome

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Else Sterndorff, Director	Haukeland University Hospital, Dept. of Physiotherapy	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bente Frisk		Sandsli		5253	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D009043	Motor Activity

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided