Frailty Rehabilitation

Not Applicable

Recruiting

• Conditions: Frailty

• Registration Number: NCT03824106
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-31
• Study Start: 2022-09-02
• Status Verified: 2024-11
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Balance Confidence	Baseline and 4-months	Dichotomous questions (y/n)
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 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 Mini-Mental State Examination \[total score\]. Higher scores indicate better cognition \[range 0-30\].
Change in Frailty	Baseline and 4-months	Frailty will be assessed with the Fit-Frailty App \[total score\]. Higher scores indicate greater frailty \[range 0-1\].
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 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 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 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 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 Falls	Baseline and 4-months	Number of falls will be assessed by self-report.
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 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 Strength	Baseline and 4-months	Strength will be assessed with a handgrip dynamometer \[kg\].
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 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 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 \[range 0-15\].

Trial Locations

Locations (1)

McMaster University - St. Peter's Hospital; 🇨🇦 Hamilton, Ontario, Canada