A pilot randomized controlled trial to improve geriatric frailty

BMC Geriatrics

Ken N Kuo¹  Chao Agnes Hsiung⁴  Ching-Yu Chen³  Jau-Yih Tsauo²  Rong-Sen Yang⁵  Hsiao-Hui Tsou⁴  Ding-Cheng Derrick Chan⁶ 

[1] Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan;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;Institute of Population Health Sciences, National Health Research Institutes, R440, 4 F, No. 17 Xu-Zhou Road, Taipei, Taiwan;Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, 35 Keyan Road, Zhunan, Miaoli County, Taiwan;Department of Orthopaedics, National Taiwan University Hospital, No.7, ChongSan S. Rd, Taipei, Taiwan;Department of Geriatrics and Gerontology, and Department of Internal Medicine, National Taiwan University Hospital, No.7, ChongSan S. Rd, Taipei, Taiwan

关键词: Community;    Effectiveness;    Intervention;    Aged;    Frailty;   

Others  :  858052
DOI  :  10.1186/1471-2318-12-58

 received in 2012-02-22, accepted in 2012-09-11,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Chan et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Rockwood K, Song X, MacKnight C, et al.: A global clinical measure of fitness and frailty in elderly people. CMAJ 2005, 173:489-495.
• [2]Fairhall N, Aggar C, Kurrle SE, et al.: Frailty Intervention Trial (FIT). BMC Geriatr 2008, 8:27. BioMed Central Full Text
• [3]Mezuk B, Edwards L, Lohman M, Choi M, Lapane K: Depression and frailty in later life: a synthetic review. Int J Geriatr Psychiatry 2012, 27(9):879-892.
• [4]Theou O, Stathokostas L, Roland KP, et al.: The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res 2011:19. article ID 569194
• [5]Lee PH, Lee YS, Chan DC: Interventions targeting geriatric frailty: a systemic review. J Clinic Geriatr Gerontol 2012, 3(2):47-52.
• [6]Kenny AM, Kleppinger A, Annis K, et al.: Effects of transdermal testosterone on bone and muscle in older men with low bioavailable testosterone levels, low bone mass, and physical frailty. J Am Geriatr Soc 2010, 58:1134-1143.
• [7]Peterson MJ, Sloane R, Cohen HJ, Crowley GM, Pieper CF, Morey MC: Effect of telephone exercise counseling on frailty in older veterans: project LIFE. Am J Mens Health 2007, 1:326-334.
• [8]Li CM, Chen CY, Li CY, Wang WD, Wu SC: The effectiveness of a comprehensive geriatric assessment intervention program for frailty in community-dwelling older people: a randomized, controlled trial. Arch Gerontol Geriatr 2010, 50(Suppl 1):S39-S42.
• [9]Fried LP, Tangen CM, Walston J, et al.: Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001, 56:M146-M156.
• [10]Fried LP, Walston JD, Ferrucci L, et al.: Frailty. In Hazzard's Geriatric Medicine and Gerontology. SIXTH edition. Edited by Halter JB. McGrall-Hill, New York; 2009:631-645.
• [11]Olde Rikkert MG, Rigaud AS, van Hoeyweghen RJ, de Graaf J: Geriatric syndromes: medical misnomer or progress in geriatrics? Neth J Med 2003, 61:83-7.
• [12]Vermeulen J, Neyens JC, van Rossum E, Spreeuwenberg MD, de Witte LP: Predicting ADL disability in community-dwelling elderly people using physical frailty indicators: a systematic review. BMC geriatrics 11:33-34.
• [13]Chang CI, Chan DC, Kuo KN, Hsiung CA, Chen CY: Vitamin D insufficiency and frailty syndrome in older adults living in a Northern Taiwan community. Arch Gerontol Geriatr 2010, 50(Suppl 1):S17-S21.
• [14]Rolland Y, Abellan van Kan G, Benetos A, et al.: Frailty, osteoporosis and hip fracture: causes, consequences and therapeutic perspectives. J Nutr Health Aging 2008, 12(5):335-346.
• [15]Clegg A, Barber S, Young J, Forster A, Iliffe S: The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial. Trials 12:143.
• [16]Chan DC, Tsou HH, Chen CY: Validation of the Chinese-Canadian study of health and aging clinical frailty scale (CSHA-CFS) telephone version. Arch Gerontol Geriatr 2010, 50:e74-e80.
• [17]Liu YM: Validation of the Taiwan International Physical Activity Questionnaire-Short Form (Doctoral Dissertation in Chinese). National Taiwan University, Taipei; 2004.
• [18]Taylor HL, Jacobs DR Jr, Schucker B, Knudsen J, Leon AS, Debacker G: A questionnaire for the assessment of leisure time physical activities. J Chronic Dis 1978, 31:741-755.
• [19]Folstein MF, Folstein SE, McHugh PR: "Mini-mental state". a practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975, 12:189-198.
• [20]Mahoney FI, Barthel DW: Functional evaluation: the barthel index. Md State Med J 1965, 14:61-65.
• [21]Spitzer RL, Williams JB, Kroenke K, et al.: Utility of a new procedure for diagnosing mental disorders in primary care. The PRIME-MD 1000 study. Jama 1994, 272:1749-1756.
• [22]Chang TJ, Tarn YH, Hsieh CL, Liou WS, Shaw JW, Chiou XG: Taiwanese version of the EQ-5D: validation in a representative sample of the Taiwanese population. J Formos Med Assoc 2007, 106:1023-1031.
• [23]Malouff JM, Thorsteinsson EB, Schutte NS: The efficacy of problem solving therapy in reducing mental and physical health problems: a meta-analysis. Clin Psychol Rev 2007, 27:46-57.
• [24]de Vries NM, Staal JB, van Ravensberg CD, Hobbelen JS, Olde Rikkert MG, Nijhuis-van der Sanden MW: Outcome instruments to measure frailty: a systematic review. Ageing Res Rev 2011, 10:104-14.
• [25]Chin APMJ, van Uffelen JG, Riphagen I, van Mechelen W: The functional effects of physical exercise training in frail older people: a systematic review. Sports Med 2008, 38:781-793.
• [26]Daniels R, van Rossum E, de Witte L, Kempen GI, van den Heuvel W: Interventions to prevent disability in frail community-dwelling elderly: a systematic review. BMC Health Serv Res 2008, 8:278. BioMed Central Full Text
• [27]Gobbens RJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM: Toward a conceptual definition of frail community dwelling older people. Nurs Outlook 2010, 58:76-86.
• [28]Villareal DT, Banks M, Sinacore DR, Siener C, Klein S: Effect of weight loss and exercise on frailty in obese older adults. Arch Intern Med 2006, 166:860-866.
• [29]Villareal DT, Chode S, Parimi N, et al.: Weight loss, exercise, or both and physical function in obese older adults. N Engl J Med 2011, 364:1218-1229.
• [30]Villareal DT, Steger-May K, Schechtman KB, et al.: Effects of exercise training on bone mineral density in frail older women and men: a randomised controlled trial. Age Ageing 2004, 33:309-312.
• [31]Villareal DT, Shah K, Banks MR, Sinacore DR, Klein S: Effect of weight loss and exercise therapy on bone metabolism and mass in obese older adults: a one-year randomized controlled trial. J Clin Endocrinol Metab 2008, 93:2181-2187.
• [32]Radloff LS: The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977(1):385-401.
• [33]Fallah N, Mitnitski A, Searle SD, Gahbauer EA, Gill TM, Rockwood K: Transitions in frailty status in older adults in relation to mobility: a multistate modeling approach employing a deficit count. J Am Geriatr Soc 2011, 59:524-529.
• [34]Gill TM, Gahbauer EA, Allore HG, Han L: Transitions between frailty states among community-living older persons. Arch Intern Med 2006, 166:418-423.
• [35]Gill TM, Gahbauer EA, Han L, Allore HG: The relationship between intervening hospitalizations and transitions between frailty States. J Gerontol A Biol Sci Med Sci 2011, 66:1238-1243.