Frailty Rehabilitation

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824106
• Other study ID #: 5500
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2, 2022
• Est. completion date: December 2, 2024

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: Sherri Smith
• Phone: 905 521 2100
• Email: smithsher[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: December 2, 2024
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Control
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.

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.
• Vitamin D
1000 IU of oral vitamin D

Locations

Country	Name	City	State
Canada	McMaster University - St. Peter's Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (53)

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Individual-level Economic Evaluation	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
Primary	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].	Baseline and 4-months
Primary	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.	Baseline and 4-months
Secondary	Change in Frailty	Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].	Baseline and 4-months
Secondary	Change in Fear of Falling	Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]	Baseline and 4-months
Secondary	Change in Balance Confidence	Dichotomous questions (y/n)	Baseline and 4-months
Secondary	Change in Falls	Number of falls will be assessed by self-report.	Baseline and 4-months
Secondary	Change in Fitness	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
Secondary	Change in Strength	Strength will be assessed with a handgrip dynamometer [kg].	Baseline and 4-months
Secondary	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.	Baseline and 4-months
Secondary	Change in Cognition	Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].	Baseline and 4-months
Secondary	Change in Cognition	Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	Change in Nutrition	Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].	Baseline and 4-months
Secondary	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].	Baseline and 4-months
Secondary	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.	Baseline and 4-months
Secondary	Change in Emergency Room Visits	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
Secondary	Change in Hospitalizations	Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.	Baseline, 4-months and additional 6-month follow-up
Secondary	Change in Institutionalization	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