Three randomized controlled trials with a two-year extension period on the effect of a multidisciplinary lifestyle program (1) for patients with rheumatoid arthritis, (2) for patients with ACPA positive arthralgia and (3) patients with osteoarthritis & metabolic syndrome.
- Conditions
- gewrichtsaandoeningen & metabool syndroomarthritismetabolic syndrome10003816
- Registration Number
- NL-OMON55868
- Lead Sponsor
- Reade
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 176
- Patients => 18 years.
- RA with low to moderate disease activity (2.6=EULAR recommendations for use in clinical practice.
- Unchanged disease modifying anti rheumatic drug (DMARD) treatment (including
unchanged dose) for at least 3 months or non-use of DMARDs, if applicable.,
ACPA positive arthralgia:
- Patients => 18 years.
- (History of) arthralgia.
- Seropositive for ACPA.
- No history of arthritis documented by a rheumatologist., Osteoarthritis &
metabolic syndrome:
- OA in hip and/or knee, diagnosed according to the criteria or the American
College of Rheumatology (without age-criterion).
- Metabolic syndrome according to the criteria defined by the National
Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III): when
3 or more of the following criteria are met: waist circumference >=102 (*) / >=88
(*) cm, fasting glucose >=6.1 mmol/l, triglycerides >=1.7 mmol/l, HDL <1.04 (*) /
<1.29 (*) mmol/l, blood pressure >=130/85 mmHg.
- Already following a (near-)vegan diet.
- Pregnancy.
- Absolute contra-indication for exercise therapy: resting systolic blood
pressure of >200 mmHg or diastolic blood pressure of >115 mmHg, acute
myocardial infarction within the last 3 months, chest pain at rest/before
exercise, other severe cardiac diseases (e.g. symptomatic aortic stenosis,
severe cardiac arrhythmias).
- Underweight (BMI<18,5 kg/m2).
- In case of smoking, unwillingness to stop smoking for at least the duration
of the study.
- Low e-health competencies (lowest proficiency according to Pharos quick
scan).
- Insufficient comprehension of Dutch language.
- Inability to be scheduled for therapy or meetings.
- Concurrent presence of other forms of joint disease than OA, RA or ACPA
positive arthralgia.
- Psychiatric disease.
- Total arthroplasty of hip or knee scheduled.
- No informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method