Frailty
Conditions
Brief summary
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
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.
Interventions
OTHERControl
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
BEHAVIORALGroup 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.
COMBINATION_PRODUCTNutrition 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.
DIETARY_SUPPLEMENTProtein Supplement
Protein supplementation will be provided.
DIETARY_SUPPLEMENTVitamin D
1000 IU of oral vitamin D
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed | 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 | Baseline and 4-months | Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fear of Falling | Baseline and 4-months | Iconographical Falls Efficacy Scale \[total score\]. Higher scores indicate greater fear of falling \[range 16-28\] |
| Change in Balance Confidence | Baseline and 4-months | Dichotomous questions (y/n) |
| Change in Falls | Baseline and 4-months | Number of falls will be assessed by self-report. |
| Change in Fitness | Baseline and 4-months | Fitness will be assessed with Fitness Trackers \[average step count per day\]. A greater number of steps indicates higher fitness level. |
| Change in Strength | Baseline and 4-months | Strength will be assessed with a handgrip dynamometer \[kg\]. |
| Change in Functional Mobility | Baseline and 4-months | 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. |
| Change in Cognition | Baseline and 4-months | Cognition will be assessed with the Montreal Cognitive Assessment \[total score\]. Higher scores indicate better cognition \[range 0-30\]. |
| Change in Health-related Quality of Life | Baseline and 4-months | Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life \[range 0-100\]. |
| Change in Life Space Mobility | Baseline and 4-months | Life space mobility will be assessed with the Life Space Assessment \[total score\]. Higher scores indicate a larger life space \[range 0-120\]. |
| Change in Instrumental Activities of Daily Living | Baseline and 4-months | Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire \[total scores\]. Lower scores indicate greater impairment \[range 0-8\]. |
| Change in Depression / Mood | Baseline and 4-months | Depression and mood will be assessed with the Geriatric Depression Scale Short-Form \[total score\]. Higher scores indicate more depressive symptoms \[range 0-15\]. |
| Change in Nutrition | Baseline and 4-months | Nutrition will be assessed with the Mini Nutritional Assessment \[total score\]. Lower scores indicate malnutrition \[range 0-14\]. |
| Change in Sarcopenia | Baseline and 4-months | 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 \[range 0-10\]. |
| Change in Muscle Mass | Baseline and 4-months | Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed. |
| Change in Emergency Room Visits | Baseline, 4-months and additional 6-month follow-up | Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization. |
| Change in Hospitalizations | Baseline, 4-months and additional 6-month follow-up | Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization. |
| Change in Institutionalization | Baseline, 4-months and additional 6-month follow-up | Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization. |
| Change in Basic Activities of Daily Living | Baseline and 4-months | Activities of daily living will be assessed with the Katz activities of daily living questionnaire \[total score\]. Lower scores indicate greater impairment \[range 0-6\]. |
| Change in Frailty | Baseline and 4-months | Frailty will be assessed with the Fit-Frailty App \[total score\]. Higher scores indicate greater frailty \[range 0-1\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Individual-level Economic Evaluation | Baseline, 4-months and additional 6-month follow-up | Individual-level economic evaluations will be assessed by changes in direct medical costs and effectiveness outcomes (e.g., quality-adjusted life years - QALYs), calculate and compare the incremental cost-effectiveness ratio (ICER) (e.g., $/ QALY gained, $/ a visit averted) against a willingness-to-pay threshold ($50,000/QALY) to show if this program of frailty rehabilitation represents good value for money. |
Countries
Canada
Contacts
Primary ContactSherri Smith
Outcome results
None listed