Effect of Du-Moxibustion Combined With Spine-Pinching Therapy on Cognitive Frailty in Older Adults With Prefrailty: Protocol for a Randomized Controlled Trial

Background: Cognitive frailty (CF), characterized by the coexistence of mild cognitive impairment and physical frailty in the absence of dementia or other neurodegenerative diseases, is a significant risk factor for dementia and functional decline in older adults. Although Du-moxibustion has shown potential benefits in improving CF, the effect of spine-pinching therapy remains underexplored. Objective: This study aims to evaluate, for the first time, the efficacy and safety of Du-moxibustion combined with spine-pinching therapy in older adults with prefrailty and CF. Methods: This is a prospective, single-center, randomized, single-blind, 4-arm parallel controlled trial. A total of 156 older adults with prefrailty and CF will be recruited and randomly assigned to 1 of 4 groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcome is the change in Montreal Cognitive Assessment score. Secondary outcomes include the Fried frailty phenotype, Barthel Index (activities of daily living), 15-item Geriatric Depression Scale, 36-item Short Form Health Survey, global frailty status, and traditional Chinese medicine syndrome scores. Outcome assessments will be performed at baseline (wk 0), midintervention (wk 6), postintervention (wk 8), and follow-up (wk 12). Results: Recruitment for this study is scheduled to commence in March 2026 and will end in June 2027 (recruitment and intervention). All follow-up and data collection activities will be finalized by October 2027. Results are anticipated to be completed in the first quarter of 2028. Conclusions: This study is expected to provide high-quality evidence for the clinical efficacy of Du-moxibustion combined with spine-pinching therapy in managing CF and contribute to the integration of traditional Chinese medicine external therapies in the promotion of healthy aging. Although the single-blind design may introduce expectancy bias, strict randomization procedures and standardized interventions will enhance the reliability and scientific rigor of the results.