An interventional study of Exercise and No exercise in Rheumatoid Arthritis, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Health services research
The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.
80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.
After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 69 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:
Females who are considered to have no childbearing potential are
Exclusion Criteria:
The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax
Behavioral: Exercise
This group will be allocated to "control" and therefore no supervised exercise regimen
Behavioral: No exercise
The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 5 min cool-down of 50% Hrmax
Behavioral: Exercise
This group will be allocated to "control" and therefore no supervised exercise regimen
Behavioral: No exercise
Supervised high-intensity interval training for 12 weeks three times per week. The supervision may be physical or online supervision
Also known as: High intensity interval training
Control group, therefore no supervised exercise regime
Change in left ventricular mass
measured by MRI scan
Time frame: 12 weeks
Visceral adipose tissue mass
measured by MRI scan
Time frame: 12 weeks
Stroke volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
Left ventricular and atrial end-diastolic volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
LVEF
Functional cardiac parameters: measured by MRI scan and echocardiography
Time frame: 12 weeks
Global longitudinal strain
Functional cardiac parameters: measured by MRI scan and echocardiography
Time frame: 12 weeks
E/A ratio
Functional cardiac parameters: measured by MRI scan and echocardiography
Time frame: 12 weeks
E/é
Functional cardiac parameters: measured by MRI scan and echocardiography
Time frame: 12 weeks
Left ventricular and atrial end-systolic volume
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
Left atrial volume index
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
Interventricular septum thickness
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
Left ventricular posterior wall thickness
Structural cardiac parameter: measured by MRI scan and echocardiography
Time frame: 12 weeks
Aortic and pulmonary distensibility and pulse wave velocity
Functional vascular parameter: measured by MRI
Time frame: 12 weeks
Subcutaneous, visceral and epicardial adipose tissue
Measured by MRI and MR spectroscopy
Time frame: 12 weeks
Intramyocardial triglyceride content
Measured by MRI and MR spectroscopy
Time frame: 12 weeks
Cardiorespiratory fitness
Measured with an incremental VO2 protocol on exercise bike
Time frame: 12 weeks
Dynamic spirometry
Pulmonary function testing
Time frame: 12 weeks
Whole body plethysmography
Pulmonary function testing
Time frame: 12 weeks
Diffusion capacity
Pulmonary function testing
Time frame: 12 weeks
Body composition
Measured by a DXA scan
Time frame: 12 weeks
Oral glucose tolerance test
75g of glucose taken while fasting
Time frame: 12 weeks
Axial accelerometer-based physical activity monitors
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 5-day period
Time frame: 5 days in week 6 of the intervention/control
Dietary intake
Self reported intake of all foods and liquids
Time frame: 3 days in the week 6 of intervention/control
Blood sample
Change in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.
Time frame: 12 weeks
Blood sample
Change in triglycerides (mmol/L). Following an overnight fast (10 hours), blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.
Time frame: 12 weeks
RA disease specific outcomes 1
Change in measures of the international Core Outcome Set for rheumatoid arthritis : 66/68 tender and swollen joint count
Time frame: 12 weeks
RA disease specific outcomes 2
Change in visual analogue scale (VAS) pain, VAS physician global assessment, VAS patient global assessment The Visual Analogue Scale (VAS) is a self-report measure consisting simply of a 100 mm horixontal line with a statement at each end representing one extreme (0mm = nothing, 100mm = extreme)
Time frame: 12 weeks
RA disease specific outcomes 3
Change in Health Assessment Questionnaire (HAQ-DI) Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
Time frame: 12 weeks
RA disease specific outcomes 4
Change in Short Form 36 (SF-36) Health Survey Questionnaire A 8-scale score within 8 domains.All items are scored so that a high score defines a more favorable health state.
Time frame: 12 weeks
RA disease specific outcomes 5
Change in the composite Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28). A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission
Time frame: 12 weeks
RA disease specific outcomes 6
Change in response criteria will be assessed according the clinical disease activity index (CDAI). The CDAI composite index quantifies disease activity in RA, by utilising four clinical parameters including tender and swollen joints and global assessment from both patient and assessor on a vasual analogue scale. CDAI interpretation score CDAI ≥ 22,1: High Activity CDAI \< 22,1 og ≥10,1: Moderate Activity CDAI \<10,0 og ≥ 2,9: Low Activity CDAI \<2,9: Remission
Time frame: 12 weeks
RA disease specific outcomes 7
Change in response criteria will be assessed according the American College of Rheumatology (ACR 20/50/70) response
Time frame: 12 weeks
RA disease specific outcomes 8
Change in response criteria will be assessed according the European League Against Rheumatism (EULAR none/good/moderate response)
Time frame: 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymised IPD obtained through this study may be provided to qualified researchers upon reasonable request.
Supporting information: Sap, Icf, Csr, Analytic code
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Rigshospitalet, Denmark