A pilot randomized controlled trial to improve geriatric frailty

• Published in: BMC geriatrics Vol. 12; no. 1; p. 58
• Main Authors: Chan, Ding-Cheng Derrick, Tsou, Hsiao-Hui, Yang, Rong-Sen, Tsauo, Jau-Yih, Chen, Ching-Yu, Hsiung, Chao Agnes, Kuo, Ken N
• Format: Journal Article
• Language: English
• Published: London BioMed Central 25.09.2012; BioMed Central Ltd; BMC
• Subjects: Aged; Aging; Alfacalcidol; Analysis; Bone density; Bones; Calcifediol; Clinical trials; Cohort Studies; Community; Density; Effectiveness; Exercise Therapy - methods; Exercise Therapy - psychology; Female; Follow-Up Studies; Frail Elderly - psychology; Frailty; Geriatrics; Geriatrics/Gerontology; Humans; Intervention; Male; Medical research; Medicine; Medicine & Public Health; Nutrition Assessment; Nutritional Status - physiology; Older people; Patient Education as Topic - methods; Physical functioning; physical health and activity; Pilot Projects; Problem Solving - physiology; Rehabilitation; Research Article; Studies; Vitamin D; Taiwan; Intervention; Frailty; Aged; Effectiveness; Community
• ISSN: 1471-2318; 1471-2318
• DOI: 10.1186/1471-2318-12-58

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 pronounce. Trial registration ClinicalTrials.gov: EC0970301