Locomotive Syndrome Digital Therapeutics Provided via a Smartphone App: Protocol for a Single-Group Trial

Locomotive syndrome (LS) is a condition in which muscle weakness and reduced motor function due to musculoskeletal disorders cause reduced mobility and physical function. In Japan, musculoskeletal disorders are the most frequent reason for requiring home support or nursing care, and the prevention and amelioration of LS are thus being emphasized. However, it is difficult for older people to make a habit of exercise therapy, which is the mainstay of LS treatment. We investigated whether digital therapy could (1) lead to behavioral change in older people and (2) prevent or improve LS in older people.

We sought to determine whether digital therapeutics (DTx) are useful for the prevention and amelioration of LS in older people, and we assessed the effects of DTx on the participants' exercise awareness and motor function.

We conducted a multicenter, prospective, longitudinal, nonrandomized, single-group study of Japanese adults aged ≥40 years who were eligible for LS checks. Each participant underwent an 8-week locomotion training (LT) intervention, and their subjective and objective motor abilities and motor awareness were objectively assessed at the following time points: baseline (before the start of the DTx), interim (4 weeks after the start of the DTx), and end (8 weeks after the start of the DTx). We evaluated the participants' objective motor function using the timed up and go (TUG) test, and we compare the results using a 3-way ANOVA with the TUG test at the 3 evaluation time points as the dependent variable. The results of the 25-question Geriatric Locomotive Function Scale, which is a subjective measure of motor function, and the results of the Behavioural Regulation in Exercise Questionnaire 3, which assesses motor awareness, were also evaluated using an ANOVA in the same way as the TUG test. The significance level was set at .05 / 3 = .0167 after Bonferroni correction.

As of April 2025, this study had enrolled 47 participants, and complete data had been gathered from 45 participants for the proposed analysis. Study participation was ongoing as of April 2025.

The study cohort will be used as a basis for further observational and intervention studies. This research could lead to more efficient use of medical resources and a reduction in financial and medical burdens on individuals and the economy, and it could support the prevention and amelioration of LS and the establishment of exercise habits among older people.

University Hospital Medical Information Network Clinical Trials Registry UMIN000053922; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061550.

DERR1-10.2196/70163.