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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1.Control | Experimental | Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D. |
|
| Arm2.Group Exercise | Experimental | Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise. |
|
| Arm3.Multi-modal Intervention | Experimental | Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Participants randomized to the control arm will not receive any of the Frailty Management Interventions. |
|
| 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 |
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| Individual-level Economic Evaluation | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherri Smith | Contact | 905 521 2100 | 77715 | smithsher@hhsc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Alexandra Papaioannou, MD, MSc | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University - St. Peter's Hospital | Recruiting | Hamilton | Ontario | L8M1W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11253156 | Background | 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. | |
| 21093719 | Background |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| D000090143 | Medication Review |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Group Exercise | Behavioral | 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 and Medication review | Combination Product | 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 Supplement | Dietary Supplement | Protein supplementation will be provided. |
|
| Vitamin D | Dietary Supplement | 1000 IU of oral vitamin D |
|
| 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 |
| Baseline, 4-months and additional 6-month follow-up |
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| 22624776 | Background | Kennedy CC, Ioannidis G, Giangregorio LM, Adachi JD, Thabane L, Morin SN, Crilly RG, Marr S, Josse RG, Lohfeld L, Pickard LE, King S, van der Horst ML, Campbell G, Stroud J, Dolovich L, Sawka AM, Jain R, Nash L, Papaioannou A. An interdisciplinary knowledge translation intervention in long-term care: study protocol for the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial. Implement Sci. 2012 May 24;7:48. doi: 10.1186/1748-5908-7-48. |
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| 41818185 | Derived | Papaioannou A, Kennedy C, Lee J, Hewston P, McArthur C, Maharaj S, Adachi J, Boulos P, Bobba R, Rabinovich A, McKenna B, Palubiski L, Mangin D, Thabane L, Marr S, Kaasalainen S, Tarride JE, Theou O, Armstrong D, Negm A, Noseworthy M, Rockwood K, Dolovich L, Abu Alrob H, Hladysh G, Thompson K, Ioannidis G. Study protocol for a multiarm, randomized controlled trial to determine the effectiveness of community-based frailty rehabilitation to improve physical function in older adults: The OPTIMAL Fitness Trial. PLoS One. 2026 Mar 12;21(3):e0343338. doi: 10.1371/journal.pone.0343338. eCollection 2026. |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |