Research question: Is a group-based, multidisciplinary treatment programme more effective than usual care in patients with systemic sclerosis?
ID
Source
Brief title
Condition
- Autoimmune disorders
- Musculoskeletal and connective tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Background: Scleroderma or systemic sclerosis is a serious auto-immune disease,
which, despite recent advances in medical treatment, considerably decreases
life expectancy as well as physical and mental functioning and overall quality
of life. Although in many other rheumatic conditions the effectiveness of a
multidisciplinary approach (including exercise therapy and patient education)
has been established, in systemic sclerosis research in this area is virtually
absent. Among patients, there is a strong need for a multidisciplinary
treatment programme, however more knowledge regarding its outcomes is needed.
In case of proven effectiveness, the programme should be offered to as many
patients as possible, however if the intervention is not effective, it should
not be recommended.
Study objective
Research question: Is a group-based, multidisciplinary treatment programme more
effective than usual care in patients with systemic sclerosis?
Study design
Methods: A randomised, controlled clinical trial among 50 patients with
systemic sclerosis.
Intervention
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 individual treatment by a rheumatologist
and additional medical specialists if needed and individual treatment by a
clinical nurse specialist, physical therapist, occupational therapist and
social worker, a supervised group exercise programme (2 times per week) and a
group education programme (6 meetings) will be offered. The other half of the
patients will receive usual care by the rheumatologist and other care providers
if needed.
Study burden and risks
Assesments: (control-group and intervention group):
1x day for screening
followed by 3 x 2 hour on the out-patient clinic in week 12 and 24
Intervention (only interventiongroup):
12 weeks, 2x a week daycare
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12211.058.06 |