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Clinical Trials in Canada / NCT03824106
Recruiting Not applicable

Frailty Rehabilitation

NCT03824106 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-09-02
Last updated
2025-07-06

Condition(s) studied

Frailty

Investigational drug(s) / intervention(s)

ControlGroup ExerciseNutrition and Medication reviewProtein SupplementVitamin D

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

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.

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.

Protein Supplement: Protein supplementation will be provided.

Vitamin D: 1000 IU of oral vitamin D

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
McMaster University - St. Peter's Hospital Hamilton Ontario Recruiting

More McMaster University trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03824106 on ClinicalTrials.gov ↗ ← All trials in Canada