Study protocol: cluster randomized controlled trial on physical-cognitive training for fall prevention in institutionalized older adults with cognitive impairment

Falls are common among institutionalized older adults, especially those with cognitive impairment. These events lead to significant injuries and decrease the quality of life. The effectiveness of fall prevention strategies, including multifactorial and multi-component interventions, remains unclear for this population. This protocol aims to comprehensively describe the study design, methodology, and procedures for implementing combined Physical-Cognitive Training (PCT) to prevent falls among resi- dents with cognitive impairment. A double-blind, cluster-randomized controlled trial will be conducted with participants aged 60 and above. At least sixty-eight residents from two institutions will be recruited, with one group receiving combined PCT and the control group receiving only physical training. The intervention consists of 30 minutes of physical training (range of motion, strengthening, balance, and deep breathing) and 20 minutes of cognitive stimulation therapy, performed twice weekly over 12 weeks. Trained instructors will deliver the intervention using a structured module, with the principal investigator overseeing adherence to the protocol. Measurements, including balance (Timed Up and Go Test), muscle strength (30’ Chair Stand Test, fear of fall (Fall Efficacy Scale-16), and number of falls, will be collected by assessors at baseline, post-intervention, and 12-week follow-up. This protocol provides a detailed framework for implementing combined interventions to prevent falls among residents with cogni- tive impairment. The protocol ensures replicability and con- tributes to evidence-based practices in long-term care settings for older adults.