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Background <p>Exercise therapy (ET) is a valuable adjunctive treatment for rheumatoid arthritis (RA). We hypothesized that ET supports maintenance of remission or low disease activity (LDA) during targeted drug therapy (TT) tapering. This pilot randomized controlled trial evaluated the feasibility, safety, and preliminary effects of individualized ET in RA patients undergoing TT tapering.</p> Methods <p>Thirty-two RA patients initiating TT tapering were randomized to receive personalized ET plus usual care (intervention group, <i>n</i> = 16) or usual care alone (control group, <i>n</i> = 16) for 16 weeks. The primary exploratory outcome was the proportion of patients maintaining remission or LDA (DAS28-ESR &lt; 3.2) by week 16 without TT re-escalation. Secondary outcomes included DAS28-ESR and its component measurements at weeks 8 and 16, health-related quality of life at week 16 (SF-12), physical activity (IPAQ), and daily step count. Safety and adherence were also assessed.</p> Results <p>All participants in the intervention group completed the 16-week ET program with high adherence. Remission or LDA was maintained in 75.0% (12/16) of patients in the intervention group and 81.3% (13/16) in the control group, with no clinically meaningful between-group difference. Although DAS28-ESR scores were comparable, a transient increase in physician visual analog scale was identified in the intervention group at week 8, which returned to the baseline by week 16. Over the 16-week period, IPAQ scores and step count tended to increase after adjustment for baseline values, whereas SF-12 mental health scores declined in the intervention group. No serious adverse events were observed.</p> Conclusions <p>In this pilot randomized controlled trial, individualized ET during TT tapering was safe and feasible. Nevertheless, transient increases in disease activity and declines in mental health indicate the need for careful clinical monitoring and psychological support. The study was not designed to evaluate efficacy outcomes and no clinically meaningful differences between the groups in remission maintenance were identified. Larger trials will be necessary to evaluate the efficacy and long-term safety of ET during TT tapering.</p>

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Personalized exercise therapy during targeted drug therapy tapering in patients with rheumatoid arthritis: a pilot randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年5月13日

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  • Shinsuke Yamada,
  • Akira Onishi,
  • Takumi Imai,
  • Ryuji Uozumi,
  • Hirotaka Yamada,
  • Kenichiro Hata,
  • Yonsu Son,
  • Kosuke Ebina,
  • Yasutaka Okita,
  • Ryota Hara,
  • Ryu Watanabe,
  • Tadashi Okano,
  • Masaki Katayama,
  • Wataru Yamamoto,
  • Yohei Oshima,
  • Hiroki Tanaka,
  • Hidenori Arai,
  • Motomu Hashimoto

摘要

Background

Exercise therapy (ET) is a valuable adjunctive treatment for rheumatoid arthritis (RA). We hypothesized that ET supports maintenance of remission or low disease activity (LDA) during targeted drug therapy (TT) tapering. This pilot randomized controlled trial evaluated the feasibility, safety, and preliminary effects of individualized ET in RA patients undergoing TT tapering.

Methods

Thirty-two RA patients initiating TT tapering were randomized to receive personalized ET plus usual care (intervention group, n = 16) or usual care alone (control group, n = 16) for 16 weeks. The primary exploratory outcome was the proportion of patients maintaining remission or LDA (DAS28-ESR < 3.2) by week 16 without TT re-escalation. Secondary outcomes included DAS28-ESR and its component measurements at weeks 8 and 16, health-related quality of life at week 16 (SF-12), physical activity (IPAQ), and daily step count. Safety and adherence were also assessed.

Results

All participants in the intervention group completed the 16-week ET program with high adherence. Remission or LDA was maintained in 75.0% (12/16) of patients in the intervention group and 81.3% (13/16) in the control group, with no clinically meaningful between-group difference. Although DAS28-ESR scores were comparable, a transient increase in physician visual analog scale was identified in the intervention group at week 8, which returned to the baseline by week 16. Over the 16-week period, IPAQ scores and step count tended to increase after adjustment for baseline values, whereas SF-12 mental health scores declined in the intervention group. No serious adverse events were observed.

Conclusions

In this pilot randomized controlled trial, individualized ET during TT tapering was safe and feasible. Nevertheless, transient increases in disease activity and declines in mental health indicate the need for careful clinical monitoring and psychological support. The study was not designed to evaluate efficacy outcomes and no clinically meaningful differences between the groups in remission maintenance were identified. Larger trials will be necessary to evaluate the efficacy and long-term safety of ET during TT tapering.