Condition category
Musculoskeletal Diseases
Date applied
13/02/2006
Date assigned
25/05/2006
Last edited
25/05/2006
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

Ms Ingvild Kjeken

ORCID ID

Contact details

National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
Boks 23 Vinderen
Oslo
0319
Norway
+47 (0)22 45 48 45
ingvild.kjeken@nrrk.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 65 years
2. AS according to the New York classification criteria
3. Ability to communicate in Norwegian

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Norway

Trial participating centre

National Resource Center for Rehabilitation in Rheumatology
Oslo
0319
Norway

Sponsor information

Organisation

The Norwegian Government (Helse Øst)

Sponsor details

Pb 404
Hamar
2303
Norway
+47 (0)62 58 55 00
postmottak@helse-ost.no

Sponsor type

Government

Website

http://www.helse-ost.no

Funders

Funder type

Government

Funder name

Norwegian government - Helse Øst (Health East)

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