Frailty Rehabilitation
NCT03824106 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324
Last updated 2025-07-06
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.
Conditions
Interventions
- 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.
- DIETARY_SUPPLEMENT
-
Vitamin D
1000 IU of oral vitamin D
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Alexandra Papaioannou, MD, MSc · McMaster University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-02
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Canada
Study Locations
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