Home-based multicomponent exercise with app-supported remote monitoring versus hospital group sessions in older adults: The GAITCARE quasi-experimental trial. (GAITCARE study)

Multicomponent exercise effectively prevents falls in older adults, but access to supervised programmes may be limited. This study compared the effectiveness of an 8-week home-based multicomponent exercise programme delivered through the VIVIFIL App with remote monitoring (intervention group, IG) versus hospital-based supervised exercise (onsite group, OG). The primary outcome was change in the Short Physical Performance Battery (SPPB) from baseline to week 8. In this multicentre, non-randomised clinical trial, adults aged ≥ 70 years attending falls assessment clinics were allocated to the IG ( n = 64) or OG ( n = 63) according to recruiting hospital. The study was approved by a single Research Ethics Committee and retrospectively registered on ClinicalTrials.gov. Median age was 83 years (79–86), and 67.3% were women. Unadjusted analyses showed no significant between-group differences in changes in SPPB, gait speed, or Timed Up and Go. Four adjusted analytical approaches consistently found no significant difference in week-8 SPPB (adjusted difference for IG: −0.49 points; 95% CI − 1.15 to 0.16; p = 0.14), although point estimates favoured the OG. Adjusted analyses also favoured the OG for grip strength (− 2.66 kg; 95% CI − 3.84 to − 1.48; p < 0.001) and frailty score (+ 0.43 criteria; 95% CI 0.16 to 0.69; p = 0.002), with the latter observed at one centre only. A sensitivity analysis indicated that the variation in SPPB observed between the two onsite centres was comparable in magnitude to the difference between groups. Thirty-eight falls occurred (IG 12; OG 26; incidence rate ratio 0.45, 95% CI 0.21–0.92). At week 4 the proportion of participants rated as showing at least a medium level of compliance was lower in the IG (43/64; 67.2%) than in the OG (59/63; 93.7%). No statistically significant between-group difference in SPPB change was observed between home-based exercise using the VIVIFIL App and hospital-based exercise, whereas supervised sessions showed advantages in some secondary outcomes. Given the non-randomised design and absence of a prespecified equivalence margin, findings should be considered exploratory and hypothesis-generating.