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NCT Number: NCT03824106

Frailty Rehabilitation

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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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University - St. Peter's Hospital

Hamilton, Ontario, L8M1W9, Canada

Location status: Recruiting

Location contact

Alexandra Papaioannou, MD, MSc

PRINCIPAL_INVESTIGATOR

Sherri Smith

CONTACT

[email protected]

905 521 2100 ext. 77715

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Participants randomized to the control arm will not receive any of the Frailty Management Interventions.

Group exercise

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

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

Dietary Supplement

Protein supplementation will be provided.

Vitamin D

Dietary Supplement

1000 IU of oral vitamin D

Primary outcomes

  1. 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].

  2. 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.

Secondary outcomes

  1. 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].

  2. 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]

  3. Change in Balance Confidence

    Time frame: Baseline and 4-months

    Dichotomous questions (y/n)

  4. Change in Falls

    Time frame: Baseline and 4-months

    Number of falls will be assessed by self-report.

  5. 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.

  6. Change in Strength

    Time frame: Baseline and 4-months

    Strength will be assessed with a handgrip dynamometer [kg].

  7. 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.

  8. 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].

  9. 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].

  10. 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].

  11. 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].

  12. 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].

  13. 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].

  14. 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].

  15. 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].

  16. 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].

  17. 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.

  18. 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.

  19. 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.

  20. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherri Smith

CONTACT

[email protected]

905 521 2100 ext. 77715

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2019
Registry last updated
Jul 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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