gewrichtsaandoeningen & metabool syndroom arthritis metabolic syndrome
Conditions
Interventions
After screening and baseline measurements (RA patients will also visit a nurse
to determine the DAS28 score), patients are randomized. Those in the
intervention group start with individual intake me
Sponsors
Reade
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients => 18 years. - RA with low to moderate disease activity (2.6= 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 =130/85 mmHg.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rheumatoid arthritis: Main endpoint for RA-patients is the difference between mean change in DAS28 scores from 0-16 weeks (measured blind by a research nurse) in the intervention and control groups. Arthralgia: Main endpoint for the ACPA positive arthralgia-patients is the difference between mean change in RA-risk scores from 0-16 weeks (measured blind by a research nurse) in the intervention and control groups. Osteoarthritis & metabolic syndrome: Main endpoint for patients with OA & MetS is the difference between the mean change in WOMAC scores from 0-16 weeks in the intervention and control groups. Two-year extension study: Main endpoint for the 2-year extension study (all groups) is the change in adherence from 0-24 months, based on a variation of the 'Lifestyle Index Adherence Score' as developed by Dean Ornish: [t + ([u / 6 + v / 60] / 2) + ([x / 5 + y / 150] / 2) + z]/4 t = attendance meetings (index, e.g. 0.2 when attended 1 of 2 meetings) u = stress reduction activities days per week v = stress reduction activities minutes per week x = exercise days per week y = exercise minutes per week z = adherence to diet In which z is defined as: [(grams of fibre per 1000 kilocalories/14) + (10/energypercentage saturated fatty acids)]/2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Parameters are equal for all patients (RA, arthralgia and OA & MetS) unless otherwise specified. General: - Self-reported physical (fatigue, pain intensity, pain interference, physical function, sleep disturbance), mental (anxiety, depression) and social (ability to participate in social roles & activities) health using the validated Dutch-Flemish PROMIS®, which only needs 3-7 questions per domain to obtain valid outcomes, quality of life and costs. Body composition: - Body weight (kg) - Body height (cm) - BMI (kg/m2) - Waist circumference (cm, at approximate midpoint between the lower margin of the last palpable rib and the top of the iliac crest). - Total fat free mass (DEXA, kg & % of body weight) - Total muscle mass (DEXA, kg & % of body weight) - Total fat mass (DEXA, kg & % of body weight) - 50% of all subjects in the RA and OA intervention groups (20 RA patients, 20 OA patients) as well as 5 RA and 5 OA patients in the control groups will be recruited for MRI examination of (1) visceral adipose tissue (VAT) (spectroscopy will be used to identify fatty acid distribution), (2)liver fat content (spectroscopy will be used to identify fatty acid distribution) and (3) intramuscular fat mass in the thigh muscle. Physical performance: - Hand grip strength (kg/force) - Function (get-up-and-go test, seconds) - Physical activity level (PAL, as coefficient related to base metabolic rate [BMR]), measured with an activity tracker Metabolic: - Blood pressure - Heart rate variability, measured by a 5-minute ECG - Lipid profile (LDL, HDL, triglycerides in blood) - Fasting Glucose (blood) - HbA1c (blood) Disease activity: - Rheumatoid factor (RF, ACPA positive arthralgia patients for all measurements, RA patients only at baseline and at the end of the one-year extension study, blood) - Anti-citrullinated Protein Antibodies (ACPA, ACPA positive arthralgia patients for all measurements, RA patients only at baseline and at the end of the on | — |
Countries
Netherlands
Outcome results
None listed