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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
324
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
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.
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.
Protein supplementation will be provided.
1000 IU of oral vitamin D
McMaster University - St. Peter's Hospital
Hamilton, Ontario, Canada
RECRUITINGChange in Physical Performance
Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].
Time frame: 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.
Time frame: Baseline and 4-months
Change in Frailty
Frailty will be assessed with the Fit-Frailty App \[total score\]. Higher scores indicate greater frailty \[range 0-1\].
Time frame: Baseline and 4-months
Change in Fear of Falling
Iconographical Falls Efficacy Scale \[total score\]. Higher scores indicate greater fear of falling \[range 16-28\]
Time frame: Baseline and 4-months
Change in Balance Confidence
Dichotomous questions (y/n)
Time frame: Baseline and 4-months
Change in Falls
Number of falls will be assessed by self-report.
Time frame: 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.
Time frame: Baseline and 4-months
Change in Strength
Strength will be assessed with a handgrip dynamometer \[kg\].
Time frame: 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.
Time frame: Baseline and 4-months
Change in Cognition
Cognition will be assessed with the Montreal Cognitive Assessment \[total score\]. Higher scores indicate better cognition \[range 0-30\].
Time frame: Baseline and 4-months
Change in Cognition
Cognition will be assessed with the Mini-Mental State Examination \[total score\]. Higher scores indicate better cognition \[range 0-30\].
Time frame: 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 \[range 0-100\].
Time frame: 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 \[range 0-120\].
Time frame: 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 \[range 0-6\].
Time frame: 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 \[range 0-8\].
Time frame: 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 \[range 0-15\].
Time frame: Baseline and 4-months
Change in Nutrition
Nutrition will be assessed with the Mini Nutritional Assessment \[total score\]. Lower scores indicate malnutrition \[range 0-14\].
Time frame: 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 \[range 0-10\].
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4-months and additional 6-month follow-up
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