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. (c) 2006, Editrice Kurtis.