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
Protocol serial number	N/A
Sponsor	The Norwegian Government (Helse Øst)
Funder	Norwegian government - Helse Øst (Health East)

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

National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway

Phone	+47 (0)22 45 48 45
Email	ingvild.kjeken@nrrk.no

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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)
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.