Rheumatism Rheumatoid Arthritis
Conditions
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, subjects must meet all of the following criteria: a. they are diagnosed with RA by a rheumatologist; b. have severe functional deterioration despite medical treatment and their functional decline can or could not be stopped or improved by a short, intermittent physical therapy intervention; c. they need longstanding active physical therapy because of severe limitations in daily activities caused by RA such as limited walking distance, problems with making transfers and/or limitations in self-care; d. their limitations in daily activities are related to pain, stiffness, muscle function decline, limited cardiopulmonary condition and or limited motor control (danger of falling), caused by high disease activity despite optimal medical treatment and/or severe joint damage and/or deformities and/or sever comorbidity (e.g. pulmonary or cardiovascular disease, depression, morbid obesity.
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participation in this study: Patients who were individually treated by a physical therapist and/or a multidisciplinary team in the setting of a rehabilitation center or rheumatology clinic or center in the last 3 months; patients in need of immediate admission to a hospital, rehabilitation center or rheumatology clinic or other forms of intensive, multidisciplinary care. Patients who are unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of effectiveness is the individual level of functioning (activities and participation), as measured with the Patient-Specific Complaints instrument (PSC) at 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include the 10-item Patient Reported Outcomes Measurement Information System (PROMIS) for Physical Function and the Health Assessment Questionnaire- Disability Index (HAQ-DI) and 6 minute walk test for functional ability; the RAQol / SF-36 for Quality of life; the EuroQol 5-D for health valuation and health care usage for substitution of care. In addition, in order to address the issue of cost-effectiveness, comprehensive measurements of all costs and an economic analysis will be conducted as well. Apart from the primary and secondary outcome measures, sociodemographic and disease characteristics, the presence of comorbidity will be recorded by means of the comorbidity questionnaire developed by the Dutch Central Bureau of Statistics . In addition, an anchor question regarding the perceived effectiveness will be added in all cases (intervention and control) where longstanding exercise therapy was used (*has the exercise therapy changed your daily functioning*), as well as a short questionnaire on patient satisfaction with treatment Furthermore, we will retrospectively evaluate the content of provided care and the compliance of the patients in the intervention group by asking the patients to fill out a registration form on the frequency, duration, and content of treatment. At 52 weeks, the perception of any side effects of exercise therapy will be recorded. If treatment is discontinued, the reasons will be recorded. | — |
Countries
Netherlands
Outcome results
None listed