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Open Access Research article

A pilot randomized controlled trial to improve geriatric frailty

Ding-Cheng Derrick Chan1, Hsiao-Hui Tsou6, Rong-Sen Yang2, Jau-Yih Tsauo3, Ching-Yu Chen45, Chao Agnes Hsiung6 and Ken N Kuo7*

Author Affiliations

1 Department of Geriatrics and Gerontology, and Department of Internal Medicine, National Taiwan University Hospital, No.7, ChongSan S. Rd, Taipei, Taiwan

2 Department of Orthopaedics, National Taiwan University Hospital, No.7, ChongSan S. Rd, Taipei, Taiwan

3 School and Graduate Institute of Phsical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan. Institution mailing address, Floor 3, No. 17, Xuzhou Rd, Taipei, Taiwan

4 Department of Family Medicine, National Taiwan University Hospital, Taipei, No 7 ChungSan S. Rd, Taipei, Taiwan

5 Institute of Population Health Sciences, National Health Research Institutes, R440, 4 F, No. 17 Xu-Zhou Road, Taipei, Taiwan

6 Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan

7 Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan

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BMC Geriatrics 2012, 12:58  doi:10.1186/1471-2318-12-58

Published: 25 September 2012

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 pronounce.

Trial registration

ClinicalTrials.gov: EC0970301

Keywords:
Frailty; Aged; Intervention; Effectiveness; Community