Frailty Rehabilitation
Primary Purpose
Frailty
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Control
Group Exercise
Nutrition and Medication review
Protein Supplement
Vitamin D
Sponsored by
About this trial
This is an interventional prevention trial for Frailty
Eligibility Criteria
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
Sites / Locations
- McMaster University - St. Peter's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm1.Control
Arm2.Group Exercise
Arm3.Multi-modal Intervention
Arm Description
Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.
Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home 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.
Outcomes
Primary Outcome Measures
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].
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.
Secondary Outcome Measures
Change in Frailty
Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].
Change in Fear of Falling
Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]
Change in Balance Confidence
Dichotomous questions (y/n)
Change in Falls
Number of falls will be assessed by self-report.
Change in Fitness
Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level.
Change in Strength
Strength will be assessed with a handgrip dynamometer [kg].
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.
Change in Cognition
Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
Change in Cognition
Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].
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].
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].
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].
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].
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].
Change in Nutrition
Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].
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].
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.
Change in Emergency Room Visits
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Change in Hospitalizations
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Change in Institutionalization
Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization.
Full Information
NCT ID
NCT03824106
First Posted
January 22, 2019
Last Updated
September 3, 2022
Sponsor
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT03824106
Brief Title
Frailty Rehabilitation
Official Title
Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
December 3, 2023 (Anticipated)
Study Completion Date
December 2, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm1.Control
Arm Type
Experimental
Arm Description
Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.
Arm Title
Arm2.Group Exercise
Arm Type
Experimental
Arm Description
Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
Arm Title
Arm3.Multi-modal Intervention
Arm Type
Experimental
Arm Description
Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.
Nutrition, protein supplementation, and a medication review will also be implemented.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Intervention Type
Behavioral
Intervention Name(s)
Group Exercise
Intervention Description
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
Combination Product
Intervention Name(s)
Nutrition and Medication review
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Protein Supplement
Intervention Description
Protein supplementation will be provided.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
1000 IU of oral vitamin D
Primary Outcome Measure Information:
Title
Change in Physical Performance
Description
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
Time Frame
Baseline and 4-months
Title
Change in Walking Speed
Description
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
Time Frame
Baseline and 4-months
Secondary Outcome Measure Information:
Title
Change in Frailty
Description
Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].
Time Frame
Baseline and 4-months
Title
Change in Fear of Falling
Description
Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]
Time Frame
Baseline and 4-months
Title
Change in Balance Confidence
Description
Dichotomous questions (y/n)
Time Frame
Baseline and 4-months
Title
Change in Falls
Description
Number of falls will be assessed by self-report.
Time Frame
Baseline and 4-months
Title
Change in Fitness
Description
Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level.
Time Frame
Baseline and 4-months
Title
Change in Strength
Description
Strength will be assessed with a handgrip dynamometer [kg].
Time Frame
Baseline and 4-months
Title
Change in Functional Mobility
Description
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.
Time Frame
Baseline and 4-months
Title
Change in Cognition
Description
Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
Time Frame
Baseline and 4-months
Title
Change in Cognition
Description
Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].
Time Frame
Baseline and 4-months
Title
Change in Health-related Quality of Life
Description
Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life [range 0-100].
Time Frame
Baseline and 4-months
Title
Change in Life Space Mobility
Description
Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].
Time Frame
Baseline and 4-months
Title
Change in Basic Activities of Daily Living
Description
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].
Time Frame
Baseline and 4-months
Title
Change in Instrumental Activities of Daily Living
Description
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].
Time Frame
Baseline and 4-months
Title
Change in Depression / Mood
Description
Depression and mood will be assessed with the Geriatric Depression Scale Short-Form [total score]. Higher scores indicate more depressive symptoms [range 0-15].
Time Frame
Baseline and 4-months
Title
Change in Nutrition
Description
Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].
Time Frame
Baseline and 4-months
Title
Change in Sarcopenia
Description
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].
Time Frame
Baseline and 4-months
Title
Change in Muscle Mass
Description
Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed.
Time Frame
Baseline and 4-months
Title
Change in Emergency Room Visits
Description
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Time Frame
Baseline, 4-months and additional 6-month follow-up
Title
Change in Hospitalizations
Description
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Time Frame
Baseline, 4-months and additional 6-month follow-up
Title
Change in Institutionalization
Description
Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization.
Time Frame
Baseline, 4-months and additional 6-month follow-up
Other Pre-specified Outcome Measures:
Title
Individual-level Economic Evaluation
Description
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.
Time Frame
Baseline, 4-months and additional 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherri Smith
Phone
905 521 2100
Ext
77715
Email
smithsher@hhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University - St. Peter's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M1W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherri Smith
Phone
905 521 2100
Ext
77715
Email
smithsher@hhsc.ca
First Name & Middle Initial & Last Name & Degree
Alexandra Papaioannou, MD, MSc
12. IPD Sharing Statement
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