Frailty Rehabilitation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Other: Control
* Behavioral: Group Exercise
* Combination Product: Nutrition and Medication review
* Dietary Supplement: Protein Supplement
* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm1.Control<br>Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D. | Other: Control<br>* Participants randomized to the control arm will not receive any of the Frailty Management Interventions.<br>Dietary Supplement: Vitamin D<br>* 1000 IU of oral vitamin D<br>|
| Experimental: Arm2.Group Exercise<br>Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise. | Behavioral: Group Exercise<br>* 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.<br>Dietary Supplement: Vitamin D<br>* 1000 IU of oral vitamin D<br>|
| Experimental: Arm3.Multi-modal Intervention<br>Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. | Behavioral: Group Exercise<br>* 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.<br>Combination Product: Nutrition and Medication review<br>* 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.<br>Dietary Supplement: Protein Supplement<br>* Protein supplementation will be provided.<br>Dietary Supplement: Vitamin D<br>* 1000 IU of oral vitamin D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Performance | Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12]. | Baseline and 4-months | 
| Change in Walking Speed | Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance. | Baseline and 4-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frailty | Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1]. | Baseline and 4-months | 
| Change in Fear of Falling | Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28] | Baseline and 4-months | 
| Change in Balance Confidence | Dichotomous questions (y/n) | Baseline and 4-months | 
| Change in Falls | Number of falls will be assessed by self-report. | Baseline and 4-months | 
| Change in Fitness | Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level. | Baseline and 4-months | 
| Change in Strength | Strength will be assessed with a handgrip dynamometer [kg]. | Baseline and 4-months | 
| Change in Functional Mobility | Strength will be assessed with the Timed Up and Go (TUG) Test [total time]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility. | Baseline and 4-months | 
| Change in Cognition | Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30]. | Baseline and 4-months | 
| Change in Cognition | Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30]. | Baseline and 4-months | 
| Change in Health-related Quality of Life | Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life [range 0-100]. | Baseline and 4-months | 
| Change in Life Space Mobility | Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120]. | Baseline and 4-months | 
| Change in Basic Activities of Daily Living | Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6]. | Baseline and 4-months | 
| Change in Instrumental Activities of Daily Living | Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8]. | Baseline and 4-months | 
| Change in Depression / Mood | Depression and mood will be assessed with the Geriatric Depression Scale Short-Form [total score]. Higher scores indicate more depressive symptoms [range 0-15]. | Baseline and 4-months | 
| Change in Nutrition | Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14]. | Baseline and 4-months | 
| Change in Sarcopenia | Sarcopenia will be assessed with the strength, assistance walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire [total score]. High scores (greater than or equal to 4) is predictive of sarcopenia [range 0-10]. | Baseline and 4-months | 
| Change in Muscle Mass | Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed. | Baseline and 4-months | 
| Change in Emergency Room Visits | Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization. | Baseline, 4-months and additional 6-month follow-up | 
| Change in Hospitalizations | Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization. | Baseline, 4-months and additional 6-month follow-up | 
| Change in Institutionalization | Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization. | Baseline, 4-months and additional 6-month follow-up |