Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Change in Walking Speed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Walking Speed
时间窗: Baseline and 4-months
Walking speed will be assessed with the 400-m Walk Test \[walking speed, m/s\]. Faster walking speeds indicate better performance.
Change in Physical Performance
时间窗: Baseline and 4-months
Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].
次要结局
- Change in Balance Confidence(Baseline and 4-months)
- Change in Fitness(Baseline and 4-months)
- Change in Functional Mobility(Baseline and 4-months)
- Change in Frailty(Baseline and 4-months)
- Change in Health-related Quality of Life(Baseline and 4-months)
- Change in Life Space Mobility(Baseline and 4-months)
- Change in Nutrition(Baseline and 4-months)
- Change in Institutionalization(Baseline, 4-months and additional 6-month follow-up)
- Change in Instrumental Activities of Daily Living(Baseline and 4-months)
- Change in Sarcopenia(Baseline and 4-months)
- Change in Falls(Baseline and 4-months)
- Change in Hospitalizations(Baseline, 4-months and additional 6-month follow-up)
- Change in Fear of Falling(Baseline and 4-months)
- Change in Strength(Baseline and 4-months)
- Change in Muscle Mass(Baseline and 4-months)
- Change in Emergency Room Visits(Baseline, 4-months and additional 6-month follow-up)
- Change in Basic Activities of Daily Living(Baseline and 4-months)
- Change in Depression / Mood(Baseline and 4-months)
- Change in Cognition(Baseline and 4-months)