A pilot randomized controlled trial to improve geriatric frailty

Background: Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome. Methods. This RCT enrolled 117 older adults (65-79years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score 1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS-PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n=55 or problem solving therapy, PST, n=57) or controls (non-EN, n=62 or non-PST, n=60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3month. Subjects were followed at 3, 6, and 12months. Primary outcome was improvement of the CHS-PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions. Results: Mean age was 71.43.7years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p=0.008) at 3months, but not 6 or 12months. They also had more increase of serum 25(OH) vitamin D level (4.97.7 vs 1.25.4, p=0.006) and lower percentage of osteopenia (74% vs 89% p=0.042) at 12months. PST group subjects had better improvement (2.76.1 vs 0.26.7, p=0.035, 6-month) and less deterioration (3.59.7 vs 7.18.7, p=0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported. Conclusions: The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounce. Trial registration. ClinicalTrials.gov: EC0970301.