Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
324 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-09-02
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Frailty
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Arm1.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.
Group Type
EXPERIMENTAL
Control
Intervention Type
OTHER
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Vitamin D
Intervention Type
DIETARY_SUPPLEMENT
1000 IU of oral vitamin D
Arm2.Group Exercise
Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
Group Type
EXPERIMENTAL
Group Exercise
Intervention Type
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.
Vitamin D
Intervention Type
DIETARY_SUPPLEMENT
1000 IU of oral vitamin D
Arm3.Multi-modal Intervention
Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.
Nutrition, protein supplementation, and a medication review will also be implemented.
Group Type
EXPERIMENTAL
Group Exercise
Intervention Type
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
Intervention Type
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
Intervention Type
DIETARY_SUPPLEMENT
Protein supplementation will be provided.
Vitamin D
Intervention Type
DIETARY_SUPPLEMENT
1000 IU of oral vitamin D
Interventions
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Control
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Intervention Type
OTHER
Group 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.
Intervention Type
BEHAVIORAL
Nutrition 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.
Intervention Type
COMBINATION_PRODUCT
Protein Supplement
Protein supplementation will be provided.
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D
1000 IU of oral vitamin D
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alexandra Papaioannou, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University - St. Peter's Hospital
Hamilton, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Reference Type
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.
Reference Type
BACKGROUND
Gafni A, Birch S. Incremental cost-effectiveness ratios (ICERs): the silence of the lambda. Soc Sci Med. 2006 May;62(9):2091-100. doi: 10.1016/j.socscimed.2005.10.023. Epub 2005 Dec 1.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5500
Identifier Type: -
Identifier Source: org_study_id
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