Rheumatoid Arthritis Clinical Trial
Official title:
Effect of Eccentric Exercise Training in Rheumatoid Cachexia
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.
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