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
Effect of Occupational Therapy in patients with Chronic Obstructive Pulmonary Disease: a randomised controlled trial
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
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 (if study stopped)
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
Total final enrolment
52
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
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
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/26982627 (added 24/01/2020)