Motor Control and Ergonomic Intervention Home-Based Program: A Pilot Trial Performed in the Framework of the Motor Control Home Ergonomics Elderlies' Prevention of Falls (McHeELP) Project.

Objectives Falls are a serious problem that can reduce living autonomy and health-related quality of life of older adults. A decrease in the muscular strength of the lower limbs and the deterioration of balance or motor performance deficits may lead to falls. "Motor Control Home Ergonomics Elderlies' Prevention of Falls" (McHeELP) is a novel motor control exercise program combined with ergonomic arrangements of the home environment. This pilot trial is conducted in order to examine the feasibility and acceptability of the McHeELP program, the selection of the most appropriate outcome measures, and the exact sample size calculation that should be used for the randomized controlled trial (RCT) with Clinical Trial Identifier: ISRCTN15936467. Patients and methods Twenty older adults (aged ≥65 years) who had experienced at least one fall-incident in the past 12 months have participated in the trial; they were randomized in a 1:1 ratio to the McHeELP group (McHeELP-G) and the Control group (CG). The McHeELP-G received a personalized therapeutic motor control and learning exercise program performed three times per week for 12 weeks. Regarding McHeELP - home modification, a booklet that contained basic advice and tips on the modification for their inside and outside home environment was provided to the participants. Objective and self-reported outcome measures, collected at baseline and post-intervention (end of the third month), included functional, fear of falling, and quality of life measurements. Results The McHeELP intervention was very feasible and acceptable to the participants, and the adherence was excellent (100%). The majority of outcome measures seemed appropriate and significant differences were also revealed between the two groups. Specifically, post-intervention statistically significant improvement was found in the 4 meters walking test, Timed Up and Go test, Sit to Stand test, Tandem Stance test, Functional Reach test, Foot tapping test, EuroQoL-5D-5L - visual analog scale (VAS), Lower Extremity Functional Scale, Falls Self-Efficacy International Scale, and Home Falls and Accidents Screening Tool (HOMEFAST) questionnaire of McHeELP-G (all p-values ≤0.002). No statistically significant difference was observed in the mobility, self-care, usual activities, pain/discomfort subscales of Euro QoL-5D-5L (all p-values >0.05), except the anxiety/depression subscale of McHeELP-G (p=0.008). Moreover, no statistically significant improvement was found regarding McHeELP participants' knee flexion/extension restriction and ankle dorsiflexion/plantar-flexion restrictions. Regarding CG, no statistically significant difference was found (p>0.05), except the Tandem Stance test (p=0.003) and HOMEFAST (p<0.001). Referring to the future McHeELP RCT, it was estimated that a sample size of 25 evaluable patients per group is required. Conclusions This pilot trial's findings suggest that it is feasible to deliver an RCT of the McHeLP program to this population. Exercise programs that are easy to administer need to be developed and implemented to reduce the burden of falls in older adults.