BACKGROUND: Older adults with (pre)frailty are vulnerable to deteriorations in physical functioning, mobility and independence. Evidence for frailty interventions utilizing existing services within primary healthcare structure is limited. The PromeTheus trial aimed to evaluate the effectiveness of a home-based, multifactorial, interdisciplinary intervention to prevent functional and mobility decline in (pre)frail older adults. METHODS: In this multicentre, assessor-blinded, randomized controlled trial, 385 community-dwelling (pre)frail older adults (clinical frailty scale 4-6, ≥ 70 years) were randomly allocated (1:1) into the intervention group (IG: n = 196) or control group (CG: n = 189). The IG underwent the PromeTheus programme for 12 months, which included an obligatory unsupervised home-based physical exercise programme and facultative counselling services (person-environment fit, nutrition and coping with everyday life), implemented through existing healthcare services and referral to community group activities. The CG received usual care. The first primary outcome was the function component of the Late-Life Function and Disability Instrument (LLFDI-FC) after 12 months; Life-Space Assessment (LSA) served as the second primary outcome. Secondary outcomes included participation (short-form LLFDI disability component, LLFDI-DC), frailty status, physical capacity (Short Physical Performance Battery, SPPB) and fall rate. Data analyses followed the intention-to-treat principle. An exploratory stratified analysis according to baseline physical capacity (SPPB ≤ 6 points n = 210 vs. SPPB > 6 points n = 175) was also conducted. RESULTS: Participants had a mean age of 81.2 ± 5.9 years, with 73.5% (n = 283) being female. At the 12-month follow-up, a significant between-group difference in favour of the IG was observed for the change in the LLFDI-FC (1.38 points, 95% confidence interval CI 0.08, 2.68) but not for the change in the LSA (0.49 points, 95% CI -3.65, 4.64). Change in frailty status (odds ratio for being in a 'better' change status 1.72, 95% CI 1.11, 2.64) and SPPB (0.58 points, 95% CI 0.10, 1.05) also showed significant between-group differences in favour of the IG. The intervention did not affect the short form LLFDI-DC or fall rate (p = 0.055-0.689). The stratified analysis showed significant improvements in the LLFDI-FC, short-form LLFDI-DC (limitation), frailty status and SPPB (p = 0.002-0.020) in the IG compared to the CG for participants with SPPB ≤ 6 points but not for those with SPPB > 6 points. There were no study-related serious adverse events. CONCLUSIONS: The PromeTheus programme had positive effects on physical functioning, frailty status and physical capacity but not on life-space mobility and fall rate in community-dwelling (pre)frail older adults. Participants with lower baseline physical capacity may benefit more from the programme.
Rapp et al. (Thu,) studied this question.