Effectiveness of acupressure foot mats in older adults with functional constipation: protocol for a randomized controlled trial

Resumen

Background Functional constipation (FC) is a prevalent gastrointestinal disorder among older adults, significantly impairing quality of life. While pharmacological treatments are common, they are often associated with adverse effects and poor long-term adherence. Acupressure is a non-pharmacological alternative, but manual application requires trained practitioners. Acupressure foot mats offer an accessible, self-administered home-based intervention with the potential to support adherence. Objective This study aims to evaluate the effectiveness of acupressure foot mats for treating FC symptoms in older adults. Methods This randomized controlled trial will recruit 192 adults aged ≥60 years with functional constipation from community health centers. Following a 14-day baseline diary period, participants will be randomly allocated (1:1) to use either an acupressure foot mat or a flat, non-textured control mat for 30 min daily over 8 weeks, followed by a 4-week follow-up period. The primary endpoint is the mean change from baseline in the weekly frequency of complete spontaneous bowel movements (CSBMs) at week 8. The key secondary endpoint is the week-8 CSBM responder rate, defined as achieving both ≥3 CSBMs per week and an increase of ≥1 CSBM per week from baseline. Other secondary outcomes include diary-recorded rescue medication use, stool consistency, straining intensity, and abdominal symptoms, together with constipation symptom severity and quality of life assessed at baseline and weeks 4, 8, and 12. Conclusion This protocol outlines a rigorous methodology to determine whether acupressure foot mats can serve as an effective, home-based management strategy for FC in older adults, empowering patients and potentially reducing reliance on laxatives. Clinical Trial Registration International Traditional Medicine Clinical Trial Registry ( http://itmctr.ccebtcm.org.cn/ ), identifier ITMCTR2026001799. Registered on 31 July 2026 (prospective registration).