Condition category
Respiratory
Date applied
28/06/2007
Date assigned
27/09/2007
Last edited
02/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Unni Martinsen

ORCID ID

Contact details

Diakonhjemmet Sykehus
Klinisk Aktivitetsavdeling
Pb 23
Vinderen
Oslo
0319
Norway
+47 22 45 15 00
unni.martinsen@diakonsyk.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

OT in COPD

Study hypothesis

Chronic Obstructive Pulmonary Disease (COPD) has functional consequences in terms of activity limitations and participation restrictions. Although there are studies evaluating the effect of multidisciplinary rehabilitation in patients with COPD, there is a lack of high quality studies examining the effect of occupational therapy on enhancing activity and participation. The aim of this study is to evaluate the effect of occupational therapy for patients with COPD compared with a group not receiving such treatment.

Ethics approval

Obtained in November 2005 from the regional Ethical Committee. Approval from Norwegian Social Science Data Service was obtained in May 2006.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

Chronic obstructive pulmonary disease

Intervention

The control group receive treatment as usual; in this case no occupational therapy from the hospital. In the study the control group will be offered OT after the last measure at 12 months.

The intervention group will be offered two to three consultations of approximately 1 - 2 hours duration, depending on the kind and severity of functional limitations. The interventional group receive individual occupational therapy, including information and practical training in energy conserving methods, breathing techniques and use of assistive technology.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Activity and participation, measured by The Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills (AMPS).

Outcomes will be measured at baseline, and after 4 and 12 months.

Secondary outcome measures

1. Health-related quality of life, measured by St. George's Respiratory Questionnaire (SGRQ)
2. Lung function examined by spirometry and pulse oximetry

Outcomes will be measured at baseline, and after 4 and 12 months.

Overall trial start date

01/05/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Amendments as of 02/12/2008: please note that point two of the inclusion criteria below has been updated as follows:
2. Aged 20 - 80 years

Initial information at time of registration:
1. Patients with moderate to severe COPD (Global Initiative on Obstructive Lung Disease [GOLD])
2. Aged 20 - 75 years
3. Limited ability to perform daily activities
4. Ability to communicate in Norwegian

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Exacerbations for last three weeks
2. Cognitive or mental impairment
3. Co-morbidity with an impact on the ability to perform daily activity

Recruitment start date

01/05/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Norway

Trial participating centre

Diakonhjemmet Sykehus
Oslo
0319
Norway

Sponsor information

Organisation

The Norwegian Foundation for Health and Rehabilitation (Helse og Rehabilitering) (Norway)

Sponsor details

Karl Johans gt 23 B
Oslo
0159
Norway
adm@helseogrehab.no

Sponsor type

Research organisation

Website

http://www.helseogrehab.no/

Funders

Funder type

Research organisation

Funder name

The Norwegian Foundation for Health and Rehabilitation (Helse og Rehabilitering) (Norway) - http://www.helseogrehab.no

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Federation of Norwegian Commercial and Service Enterprises (HSH) (Norway) - http://www.hsh-org.no

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Norwegian Association of Occupational Therapists (NETF) (Norway) - http://www.netf.no

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes