Frailty Rehabilitation

December 27, 2023 updated by: McMaster University

Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8M1W9
        • Recruiting
        • McMaster University - St. Peter's Hospital
        • Contact:
        • Principal Investigator:
          • Alexandra Papaioannou, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Control
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Dietary supplement: Vitamin D
1000 IU of oral vitamin D
Experimental: Arm2.Group Exercise
Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
Dietary supplement: Vitamin D
1000 IU of oral vitamin D
Behavioral: 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.
Experimental: 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.
Dietary supplement: Vitamin D
1000 IU of oral vitamin D
Behavioral: 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.
Combination product: 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.

Dietary supplement: Protein Supplement
Protein supplementation will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Performance
Time Frame: 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].
Baseline and 4-months
Change in Walking Speed
Time Frame: 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.
Baseline and 4-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Frailty
Time Frame: Baseline and 4-months
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
Time Frame: Baseline and 4-months
Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]
Baseline and 4-months
Change in Balance Confidence
Time Frame: Baseline and 4-months
Dichotomous questions (y/n)
Baseline and 4-months
Change in Falls
Time Frame: Baseline and 4-months
Number of falls will be assessed by self-report.
Baseline and 4-months
Change in Fitness
Time Frame: 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.
Baseline and 4-months
Change in Strength
Time Frame: Baseline and 4-months
Strength will be assessed with a handgrip dynamometer [kg].
Baseline and 4-months
Change in Functional Mobility
Time Frame: 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.
Baseline and 4-months
Change in Cognition
Time Frame: Baseline and 4-months
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
Time Frame: Baseline and 4-months
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
Time Frame: 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].
Baseline and 4-months
Change in Life Space Mobility
Time Frame: 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].
Baseline and 4-months
Change in Basic Activities of Daily Living
Time Frame: 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].
Baseline and 4-months
Change in Instrumental Activities of Daily Living
Time Frame: 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].
Baseline and 4-months
Change in Depression / Mood
Time Frame: 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].
Baseline and 4-months
Change in Nutrition
Time Frame: Baseline and 4-months
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
Time Frame: 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].
Baseline and 4-months
Change in Muscle Mass
Time Frame: 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.
Baseline and 4-months
Change in Emergency Room Visits
Time Frame: 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.
Baseline, 4-months and additional 6-month follow-up
Change in Hospitalizations
Time Frame: Baseline, 4-months and additional 6-month follow-up
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
Time Frame: 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.
Baseline, 4-months and additional 6-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual-level Economic Evaluation
Time Frame: Baseline, 4-months and additional 6-month follow-up
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.
Baseline, 4-months and additional 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Alexandra Papaioannou, MD, MSc, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2022

Primary Completion (Estimated)

August 2, 2024

Study Completion (Estimated)

December 2, 2024

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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