title: A pilot randomized controlled trial to improve geriatric frailty.
abstract: 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 (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 3 month. Subjects were followed at 3, 6, and 12 months. 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 71.4 ± 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.
  
  
  BACKGROUND
  ClinicalTrials.gov: EC0970301
authors.affiliation: Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan.
authors.forename: Ding-Cheng Derrick
authors.initials: DC
authors.lastname: Chan
authors.forename: Hsiao-Hui
authors.initials: HH
authors.lastname: Tsou
authors.forename: Rong-Sen
authors.initials: RS
authors.lastname: Yang
authors.forename: Jau-Yih
authors.initials: JY
authors.lastname: Tsauo
authors.forename: Ching-Yu
authors.initials: CY
authors.lastname: Chen
authors.forename: Chao Agnes
authors.initials: CA
authors.lastname: Hsiung
authors.forename: Ken N
authors.initials: KN
authors.lastname: Kuo
mesh_terms: D000368:Aged; D015331:Cohort Studies; D005081:Exercise Therapy / Q000379:methods* / Q000523:psychology; D005260:Female; D005500:Follow-Up Studies; D016330:Frail Elderly / Q000523:psychology; D006801:Humans; D008297:Male; D015596:Nutrition Assessment; D009752:Nutritional Status / Q000502:physiology; D010353:Patient Education as Topic / Q000379:methods*; D010865:Pilot Projects; D011340:Problem Solving / Q000502:physiology