scleroderma systemic sclerosis
Conditions
Interventions
Half of the patients will be randomly allocated to a multidisciplinary day
treatment programme with a duration of 12 weeks and 2 treatment days per week,
in groups of 4-6 patients. Apart form indivi
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessments will be executed at baseline and after 12 and 24 weeks by a blinded assessor. Primary outcome measures are the 6-minute walk test (m) and the physical component summary scale of the Short Form-36, a quality of life measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include measures of physical functioning (aerobic capacity, grip strength, hand function and mouth opening, daily activities), mental functioning (anxiety, depression) and overall quality of life. Moreover, patient satisfaction with the programme will be measured. Statistical analysis will be done on intention-to-treat basis, by means of analysis of variance. | — |
Countries
Netherlands
Outcome results
None listed