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BACKGROUND: Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome. METHODS: This RCT enrolled 117 older adults (65-79 years 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 (CHSPCF). 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 3 month. Subjects were followed at 3, 6, and 12 months. Primary outcome was improvement of the CHSPCF 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. 4 ± 3. 7 years, 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 3 months, but not 6 or 12 months. They also had more increase of serum 25 (OH) vitamin D level (4. 9 ± 7. 7 vs 1. 2 ± 5. 4, p = 0. 006) and lower percentage of osteopenia (74% vs 89% p = 0. 042) at 12 months. PST group subjects had better improvement (2. 7 ± 6. 1 vs 0. 2 ± 6. 7, p = 0. 035, 6-month) and less deterioration (-3. 5 ± 9. 7 vs -7. 1 ± 8. 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 pronounced. TRIAL REGISTRATION: ClinicalTrials. gov: EC0970301
Chan et al. (Tue,) studied this question.