Frailty Rehabilitation

Официальное название

Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging

Обзор

Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.

Подробное описание

In this multi-arm randomized controlled trial (RCT), 324 community-dwelling older adults (aged 65+) with frailty and at high risk for mobility disability will be randomized into one of three arms (control, exercise only, multi-modal rehabilitation) stratified by sex, age and location preference. Rolling recruitment will occur with ten cohorts total (2-3 cohorts per site, n=33 participants per cohort), enrolled across the partner Young Men's Christian Association (YMCA) sites.

Building upon the RCT, we aim to understand which components of a functional rehabilitation program are essential to change the trajectory of sarcopenia in older adults and explore the feasibility of a functional rehabilitation program with older adults. All participants will be screened for sarcopenia at baseline. Of the 324 participants, a subset of participants with sarcopenia will undergo additional assessments.

A validated frailty questionnaire can be administered over the phone and will provide an estimate of frailty status.

Stratified block randomization (1:1 randomization ratio) with the allocation sequence generated by a computer will be used to randomly allocate eligible participants to their group assignment. Participants will be stratified based on their sex, age (\<80 or \>=80 years), and location preference. To protect against selection bias, the randomization sequence will be adequately concealed so that investigators/participants are not aware of the upcoming assignment. The proposed duration of treatment is 4-months.

Primary and secondary outcomes will be assessed at 0 and 4-months.

Вмешательства

• Другое Control
  Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
• Поведенческое Group Exercise
  A recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults.
• Комбинированный продукт Nutrition and Medication review
  Nutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching. Protein supplements will be provided to all participants unless contraindicated. Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist.
• Пищевая добавка Protein Supplement
  Protein supplementation will be provided.
• Пищевая добавка Vitamin D
  1000 IU of oral vitamin D

Первичные конечные точки

• Change in Physical Performance [Срок оценки: Baseline and 4-months]
• Change in Walking Speed [Срок оценки: Baseline and 4-months]

Вторичные конечные точки (12)

• Change in Frailty [Срок оценки: Baseline and 4-months]
• Change in Fear of Falling [Срок оценки: Baseline and 4-months]
• Change in Balance Confidence [Срок оценки: Baseline and 4-months]
• Change in Falls [Срок оценки: Baseline and 4-months]
• Change in Fitness [Срок оценки: Baseline and 4-months]
• Change in Strength [Срок оценки: Baseline and 4-months]
• Change in Functional Mobility [Срок оценки: Baseline and 4-months]
• Change in Cognition [Срок оценки: Baseline and 4-months]
• Change in Cognition [Срок оценки: Baseline and 4-months]
• Change in Health-related Quality of Life [Срок оценки: Baseline and 4-months]
• Change in Life Space Mobility [Срок оценки: Baseline and 4-months]
• Change in Basic Activities of Daily Living [Срок оценки: Baseline and 4-months]

Критерии участия

Критерии включения

• Community-dwelling ≥65 years of age
• Able to independently ambulate 25m with or without walking aid
• At high risk for mobility disability/functional limitations
• Received medical clearance
• Can arrange transportation to the YMCA up to 2x/week
• Proof of being fully vaccinated against COVID-19 and proof of identification

Критерии исключения

• Unable to speak or understand English
• Currently attending a group exercise program
• Currently in a drug optimization study/program
• Currently taking protein supplements daily
• Significant cognitive impairment where they may have difficulty following two-step commands in group exercise
• Receiving palliative/end of life care
• Unstable angina or heart failure
• Unable to attend for more than 20% of trial duration

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

• McMaster University - St. Peter's Hospital — Hamilton

Публикации

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. PMID 11253156
• Rockwood K, Mitnitski A. Frailty defined by deficit accumulation and geriatric medicine defined by frailty. Clin Geriatr Med. 2011 Feb;27(1):17-26. doi: 10.1016/j.cger.2010.08.008. PMID 21093719
• Kennedy CC, Ioannidis G, Rockwood K, Thabane L, Adachi JD, Kirkland S, Pickard LE, Papaioannou A. A Frailty Index predicts 10-year fracture risk in adults age 25 years and older: results from the Canadian Multicentre Osteoporosis Study (CaMos). Osteoporos Int. 2014 Dec;25(12):2825-32. doi: 10.1007/s00198-014-2828-9. Epub 2014 Aug 8. PMID 25103215
• Rockwood K, Song X, Mitnitski A. Changes in relative fitness and frailty across the adult lifespan: evidence from the Canadian National Population Health Survey. CMAJ. 2011 May 17;183(8):E487-94. doi: 10.1503/cmaj.101271. Epub 2011 Apr 26. PMID 21540166
• Roberts KC, Rao DP, Bennett TL, Loukine L, Jayaraman GC. Prevalence and patterns of chronic disease multimorbidity and associated determinants in Canada. Health Promot Chronic Dis Prev Can. 2015 Aug;35(6):87-94. doi: 10.24095/hpcdp.35.6.01. PMID 26302227
• Rockwood K, Howlett SE, MacKnight C, Beattie BL, Bergman H, Hebert R, Hogan DB, Wolfson C, McDowell I. Prevalence, attributes, and outcomes of fitness and frailty in community-dwelling older adults: report from the Canadian study of health and aging. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1310-7. doi: 10.1093/gerona/59.12.1310. PMID 15699531
• Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65. PMID 23497404
• Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022. PMID 23764209

Идентификаторы

NCT: NCT03824106 · 5500

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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