An interventional study of Eccentric exercise and Concentric exercise in Rheumatoid Arthritis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to female participants aged 40 Years to 66 Years. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Treatment
The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.
Rheumatoid arthritis (RA) is characterized by severe disability and metabolic changes leading to an increase in cardiovascular mortality compared with the general population. RA is an independent cardiovascular risk factor. In contrast to the general population, RA patients with low body mass index (BMI) had a significantly higher risk of cardiovascular death. Low BMI may indicate rheumatoid cachexia and may explain the excess cardiovascular risk and mortality. Cachexia is defined by is a loss of body cell mass, predominantly in skeletal muscle, associated with increased fat mass and often stable weight. Rheumatoid cachexia, not well recognized, is frequent, affecting two third of patients. Pathogenesis may include inflammatory cytokine production, physical inactivity, higher catabolism and reduced peripheral insulin action. Therapeutic strategy includes increasing physical activity and the treatment of disease itself. Studies have shown that regular progressive resistance strength training improves strength and pain in patients with well-controlled RA without exacerbating disease activity or joint pain. At comparable mechanical power output, eccentric (ECC ) exercises are characterised by lower metabolic demand than concentric (CON) exercises. ECC exercise is characterised not only by its low energy cost, but also by specific cardiocirculatory specificity. In patients with Parkinson's disease, compared to a conventional rehabilitation programme, ECC training better improved quadriceps muscle volume. In overweight and diabetic patients, ECC training improved resting energy expenditure and fat oxidation, blood lipid profile and insulin resistance compared to CON training. As in cancers, ECC training appears to be particularly suitable for patients with rheumatoid cachexia as it can maximize the functional and structural muscle responses with low energy cost populations.
This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months. Secondary outcomes are the improvement in muscle mass, functional status and cardiovascular risk. From patients who consented in ECC training group, muscle biopsy specimens from vastus lateralis will be obtained at baseline prior to the training period. Primary and secondary outcome criteria will be assessed at inclusion, at 3 months, and 6 months.
In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the 3 groups, with each group comprising 16 patients: group 1 with ECC training, group 2 with CONC training, group 3 with no training (control). The training program will consist in 30 sessions over 12 weeks.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 48 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Thirty sessions of Eccentric training in twelve weeks. Average of two sessions per week without spacing higher than eight days between two sessions.
Other: Eccentric exercise
Thirty sessions of Concentric training in twelve weeks. Average of three sessions per week without spacing higher than eight days between two sessions.
Other: Concentric exercise
Usual activities. No further training during the observation period
This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months.
The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.
Isometric knee extensor strength gain measured by an isokinetic dynamometer
Time frame: at 3 months
improvement in muscle mass
quadriceps muscle volume
Time frame: Up to 30 days before the beginning of the training, after 3 and 6 months
improvement in fonctional status
Body composition : Lean body mass, Appendicular lean mass
Time frame: At the beginning of the training, after 3 and 6 months
improvement in cardiovascular risk
Cardiovascular risk : arterial compliance
Time frame: At the beginning of the training, after 3 and 6 months
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand