A randomized, controlled trial of disability prevention in frail older patients screened in primary care: the FRASI Study. Design and baseline evaluation

Background and aims: We describe the enrollment and intervention phases of FRASI (FRAilty, Screening and Intervention), a randomized controlled trial aimed at preventing ADL disability in frail older persons screened in primary care. Methods: Patients, 70–85 years old, non-disabled and non-cognitively impaired, were screened for frailty (score ≤9 on the Short Physical Performance Battery, SPPB) during primary care visits. Of 447 eligible persons, 410 came to the study clinic and 251 were randomized into treatment (n=126) and control groups (n=125). The active group received an intensive medical intervention, and sixteen 90-minute supervised exercise sessions over 8 weeks. The primary outcome was time to ADL disability onset or death in the 12-month period after study enrollment. Results: The two study arms were similar for demographics, cognitive function, physical function and health status. Compared with a population-based sample selected according to FRASI inclusion criteria except SPPB score, FRASI participants had significantly worse health and functional status. Restricting the comparison to persons with SPPB ≤9, all differences disappeared. The 99 participants (78.6% of 126) who completed the intervention participated in a mean of 15.3±1.6 exercise sessions. Conclusions: Screening in primary care for non-disabled, older persons with SPPB ≤9 yields individuals with substantial morbidity, impairments and functional limitations that can be successfully involved in an intensive medical and exercise intervention. Whether such an intervention effectively prevents new disability remains to be confirmed.