Effect of a multidisciplinary in-patient rehabilitation program for patients with ankylosing spondylitis: a randomised controlled trial
| ISRCTN | ISRCTN75685576 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75685576 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/02/2006
- Registration date
- 25/05/2006
- Last edited
- 03/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Ingvild Kjeken
Scientific
Scientific
National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway
| Phone | +47 (0)22 45 48 45 |
|---|---|
| ingvild.kjeken@nrrk.no |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Effect of a multidisciplinary in-patient rehabilitation program for patients with ankylosing spondylitis: a randomised controlled trial |
| Study objectives | Although treatment of patients with ankylosing spondylitis (AS) frequently includes exercise therapies and multidisciplinary interventions, there is a lack of high quality studies that examine the effect of such programs. This study is aimed at evaluating the effect of a multidisciplinary in-patient rehabilitation program compared to community-based standard physiotherapy for patients with AS. |
| Ethics approval(s) | Ethical approval was obtained in 2005 from the Regional Ethical Committee (ref. 738-05259 1.2005.2256), and approval from the Data Inspectorate is in progress as of 13/02/2006. |
| Health condition(s) or problem(s) studied | Ankylosing spondylitis (AS) |
| Intervention | The study is a prospective, randomised, controlled (two arm) trial. The two groups are: 1. A three-week multidisciplinary in-patient rehabilitation program 2. Standard community-based physiotherapy |
| Intervention type | Other |
| Primary outcome measure | 1. Physical function, measured by the Bath ankylosing spondylitis functional index (BASFI) 2. Pain, stiffness, fatigue and disease activity: Bath ankylosing spondylitis disease activity index (BASDAI) |
| Secondary outcome measures | 1. Self-efficacy: the Arthritis Self-Efficacy Scale (ASES) 2. General health: the Short Form-36 and the BAS Patient Global Score (BAS-G)3. Joint mobility: BAS Metrology Index (BASMI) 4. Biological signs of inflammation: erythrocyte sedimentation rate and C-reactive protein 5. Activity and participation: the Canadian Occupational Performance Measure (COPM) 6. Sleep quality: the Pittsburgh Sleep Quality Index 7. Fatigue: BASDAI, SF-36 (vitality scale) and the Multidimensional Fatigue Inventory 8. Use of medications and health care resources |
| Overall study start date | 01/01/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 95 |
| Key inclusion criteria | 1. Aged between 18 and 65 years 2. AS according to the New York classification criteria 3. Ability to communicate in Norwegian |
| Key exclusion criteria | 1. Coronary heart disease 2. Surgery or rehabilitation last six months 3. Cognitive impairment or mental disease 4. Pregnancy 5. Change in medication last month 6. BASDAI score <40 mm |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Norway
Study participating centre
National Resource Center for Rehabilitation in Rheumatology
Oslo
0319
Norway
0319
Norway
Sponsor information
The Norwegian Government (Helse Øst)
Government
Government
Pb 404
Hamar
2303
Norway
| Phone | +47 (0)62 58 55 00 |
|---|---|
| postmottak@helse-ost.no | |
| Website | http://www.helse-ost.no |
"ROR" |
https://ror.org/02qx2s478 |
Funders
Funder type
Government
Norwegian government - Helse Øst (Health East)
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 | 01/03/2013 | 03/05/2019 | Yes | No |
Editorial Notes
03/05/2019: Publication reference and total final enrolment added.
