ADL- Training for Patients With Chronic Obstructive Pulmo... | NCT00887705

Studies
ADL- Training for Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00887705

Sponsor

LHL Helse

Status

Completed

Last Update Posted

Jun 23, 2010Estimated

Enrollment

24Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

ADL training

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

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Apr 14, 2009

First Submission Date that Met QC Criteria

Apr 23, 2009

First Posted Date

Apr 24, 2009Estimated

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

Jun 22, 2010

Last Update Posted Date

Jun 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Standard rehabilitation programme	No Intervention
2. Additional ADL training	Experimental		Behavioral: ADL training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ADL training	Behavioral	The control group gets the standard rehabilitation programme which includes one hour ADL- training. The experimental group also gets the standard rehabilitation program, but instead of one hour they get an additional five hours ADL- training.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Canadian Occupational Performance Measure(COPM) - Self-perception of occupational performance and satisfaction.		Baseline, 4 weeks; 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD
Referred for rehabilitation
Age > 18 years
Symptoms affecting ADL function
6 minute walk distance (6MWD) < 400 meters

Exclusion Criteria:

Patients who smokes or has smoked during the last three months.
LTOT
Patients who has another disability
Patients who can't read or speak Norwegian

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morten S Ryg, Dr philos	LHL Helse	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glittreklinikken		Hakadal	Akershus	1485	Norway
Glittreklinikken

References Module

Citations

Not provided

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