Frailty Rehabilitation
- Conditions
- Frailty
- Interventions
- Behavioral: Group ExerciseOther: ControlDietary Supplement: Vitamin DCombination Product: Nutrition and Medication reviewDietary Supplement: Protein Supplement
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
- 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
- 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
- Arm && Interventions
Group Intervention Description Arm3.Multi-modal Intervention Group Exercise Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. Arm1.Control Vitamin D Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D. Arm3.Multi-modal Intervention Protein Supplement Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. Arm3.Multi-modal Intervention Vitamin D Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. Arm3.Multi-modal Intervention Nutrition and Medication review Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. Arm1.Control Control 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 Group Exercise Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise. Arm2.Group Exercise Vitamin D Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
- 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 Falls Baseline and 4-months Number of falls will be assessed by self-report.
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 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