Effectiveness of a multidisciplinary team care programme in comparison with usual care for patients with sclerodermia: a randomised, controlled trial.
Completed
- Conditions
- sclerodermasystemic sclerosis1000381610028393
- Registration Number
- NL-OMON30009
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
*Scleroderma according 1980 ACR criteria
*age 18-70 years
*able to cycle on a bicycle ergometer
*able to engage in a day patient programme 2 times a week over 12 continuous weeks
*able to reach the hospital at 10.00 am
*stable anti-rheumatic medication over the past 2 months
*fluent in Dutch
Exclusion Criteria
*Inability to tolerate exercise training due te the preCence of serious cardiac or andlung involvement
*current engagement in a multidisciplinary or group exercise therapy programme
*planned hospitalization or surgery in the next 6 months
*psychiatric disorders including alcolhol or drugs abuse
*concomitant diseases interfering with the performance of daily activities
*pregnancy or planned pregnancy in the next 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessments will be executed at baseline and after 12 and 24 weeks by a blinded<br /><br>assessor. Primary outcome measures are the 6-minute walk test (m) and the<br /><br>physical component summary scale of the Short Form-36, a quality of life<br /><br>measure. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include measures of physical functioning (aerobic<br /><br>capacity, grip strength, hand function and mouth opening, daily activities),<br /><br>mental functioning (anxiety, depression) and overall quality of life. Moreover,<br /><br>patient satisfaction with the programme will be measured. Statistical analysis<br /><br>will be done on intention-to-treat basis, by means of analysis of variance.</p><br>