Effect of Occupational Therapy in patients with Chronic Obstructive Pulmonary Disease: a randomised controlled trial
| ISRCTN | ISRCTN79533637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79533637 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/06/2007
- Registration date
- 27/09/2007
- Last edited
- 24/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Unni Martinsen
Scientific
Scientific
Diakonhjemmet Sykehus
Klinisk Aktivitetsavdeling
Pb 23, Vinderen
Oslo
0319
Norway
| Phone | +47 22 45 15 00 |
|---|---|
| unni.martinsen@diakonsyk.no |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | Effect of Occupational Therapy in patients with Chronic Obstructive Pulmonary Disease: a randomised controlled trial |
| Study acronym | OT in COPD |
| Study objectives | 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(s) | Obtained in November 2005 from the regional Ethical Committee. Approval from Norwegian Social Science Data Service was obtained in May 2006. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2007 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 52 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Norway
Study participating centre
Diakonhjemmet Sykehus
Oslo
0319
Norway
0319
Norway
Sponsor information
The Norwegian Foundation for Health and Rehabilitation (Helse og Rehabilitering) (Norway)
Research organisation
Research organisation
Karl Johans gt 23 B
Oslo
0159
Norway
| adm@helseogrehab.no | |
| Website | http://www.helseogrehab.no/ |
Funders
Funder type
Research organisation
The Norwegian Foundation for Health and Rehabilitation (Helse og Rehabilitering) (Norway) - http://www.helseogrehab.no
No information available
The Federation of Norwegian Commercial and Service Enterprises (HSH) (Norway) - http://www.hsh-org.no
No information available
The Norwegian Association of Occupational Therapists (NETF) (Norway) - http://www.netf.no
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2017 | 24/01/2020 | Yes | No |
Editorial Notes
24/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
