Abstract / Summary
BackgroundAlthough resistance training with nutritional intervention is recommended for sarcopenia, effective programs are often difficult to implement in patients with rheumatoid arthritis (RA). This pilot study aimed to assess the feasibility and safety of a 6-month outpatient rehabilitation program combining therapeutic electrical stimulation (TES) using belt electrodes with nutritional management in patients with RA.MethodsThis pilot study was conducted as a prospective observational study with a single-arm before–after framework and enrolled outpatients with RA in remission or with low disease activity. Participants received an outpatient rehabilitation program as part of routine clinical practice once or twice weekly over 6 months, including TES applied to the lower limbs using belt electrodes (20 min per session; 20 Hz; maximum tolerable intensity) and the daily intake of an L-leucine-enriched protein-containing nutritional supplement. Feasibility and safety were evaluated based on study completion, TES session frequency, verbally confirmed adherence to nutritional supplementation, adverse events documented during the program, and maintenance of disease activity. Lower-limb lean mass, knee extensor muscle strength, and gait speed were assessed as exploratory clinical outcomes at baseline and after 6 months.ResultsOf the 14 recruited outpatients with RA, 10 completed both the 6-month program and the final outcome assessment, corresponding to a study completion rate of 71.4%. Participants received a median of 34.5 TES sessions over 6 months. As exploratory clinical outcomes, the median paired changes in lower-limb lean mass, knee extensor muscle strength, and gait speed were 0.08 kg (95% confidence interval [CI], 0.00 to 0.25; P = 0.043), 1.58 kgf (95% CI, −0.35 to 7.25; P = 0.084), and 0.18 m/s (95% CI, −0.04 to 0.24; P = 0.084), respectively. Disease activity remained within the low disease activity to remission range and did not significantly change during the 6-month observation period (P = 0.214). No joint-related or cardiovascular adverse events were documented.ConclusionsThis pilot study provides preliminary information on the feasibility and safety of a 6-month outpatient rehabilitation program combining TES using belt electrodes and nutritional management in patients with RA. These findings may inform the design of future studies.