Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
Individualised structured exercise training. Participants will be randomly assigned to either an exercise (intervention) or a non-exercise (control) group.
Intervention:
Based on the results of an
10 minutes warm-up, 30 - 40 minutes main session, and 5 - 10 minutes cooling down. Mode, intensity, duration and frequency of exercise will be reconsidered every month, in line with the principles of
Sponsors
Dudley Group of Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with rheumatoid arthritis (both genders, aged greater than 18 years of age) 2. Informed consent 3. Sedentary lifestyle (no participation in structured exercise for the preceding 6 months) 4. Stable disease (no changes in disease-modifying anti-rheumatic drugs [DMARDs] - including biologics - or oral steroids and no parenteral steroid administration in the last 3 months)
Exclusion criteria
Exclusion criteria: 1. Recent joint surgery (in the preceding 6 months) 2. Amputation 3. Recent DMARD or oral steroid changes (in the preceding 3 months) 4. Parenteral steroid administration (in the preceding 3 months) 5. Co-morbidity incompatible with exercise as per American College of Sports Medicine guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiorespiratory fitness (CRF) has been selected as the primary end-point because of its importance as a surrogate predictor of cardiovascular events and because it is the only relevant parameter that has been previously assessed pre- and post-exercise interventions in RA patients. In studies with RA patients, or healthy participants exhibiting similar baseline CRF values to RA patients, CRF increased by approximately 20% (standard deviation [SD] = 6.0) following exercise interventions similar to the one we are proposing. We, therefore, included in our power calculation (nQuery Advisor v 6.0, Statistical Solutions, MA, USA) 20% as the expected change (i.e., from 25 ml/kg/min to 30 ml/kg/min) with SD = 6.0. The desirable number of participants for our study to produce significant results (p = 0.05) with a power of greater than 0.80, is 19 in each group. To allow for participant attrition, estimated at 25% for the six-month exercise intervention, we will recruit 25 RA patients in each of the groups. Data from participants with less than 75% compliance will be excluded from the analyses. Assessment of CRF: Exercise tolerance testing (ETT) will be adopted. Depending on each patient's functional limitations, a treadmill, a cycle ergometer or an arm ergometer will be utilised. CRF will be determined using a calibrated breath-by-breath system (Metalyzer 3B, CORTEX Biophysik GmbH, Leipzig, Germany) allowing continuous measurement of oxygen uptake (VO2), and lung ventilation. During ETT, blood pressure, heart rate and cardiac function using a 12 lead electrocardiogram (ECG), will also be monitored. Relevant data will be automatically stored every 30 seconds. Heart rate corresponding to 70% VO2max will be used to determine optimum exercise intensity. Treadmills and cycles are the most commonly used devices for clinical exercise testing. The treadmill provides a more common form of exercise (i.e., walking) and patients are more likely to attain a higher oxygen consumption c | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular outcomes: 1. Individual risk factors for the development of cardiovascular disease (CVD) and 10-year CVD event probability: individual CVD risk factors (i.e. hypertension, hyperlipidaemia, hyperinsulinaemia) will be assessed. On the basis of these, the 10-year CVD event probability will be calculated using the latest version of the Joint British Societies' risk calculator. 2. In vivo endothelial function: endothelial function in the macrovasculature will be assessed using flow mediated dilation when the patient is in a fasted state. The brachial artery will be monitored by Doppler Ultrasound (ACUSON Antares ultrasound system with a VF 10-5 Transducer and SieClear, BW SieScape Imaging software, Siemens PLC, Munich, Germany) before, during, and after flow mediated dilation as well as administration of a single dose of nitro-glycerine (Glyceryl Trinitrate oral spray). 3. Endothelial function in the microvasculature will be assessed using Laser Doppler dual wavelength imaging (Moor LDI-2 SIM, Moor Instruments Ltd, Devon, UK). Acetylcholine, an endothelium-dependent vasodilator, and sodium nitroprusside, and endothelium-independent vasodilator, will be separately administered by iontophoresis. Blood flow will be assessed continuously 1 minute before iontophoresis and 2 minutes after iontophoresis using laser Doppler imaging. Rheumatoid arthritis outcomes: 1. Disease activity: using the disease activity score 28 (DAS28). This is a composite assessment consisting of the patient's self-assessment of overall health during the last week on a visual analogue scale, a 28-joint count and the current erythrocyte segmentation rate (ESR). Serological assessments of disease activity are described below. 2. Physical function: using the Anglicised version of the 40-item Stanford Health Assessment Questionnaire (HAQ). Participants will rate their ability (over the past week) to carry out 20 activities within eight aspects of daily living (dressing/grooming, rising, eat | — |
Countries
United Kingdom
Outcome results
None listed