Clinical trial
Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
Name
5500
Description
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.
Trial arms
Trial start
2022-09-02
Estimated PCD
2024-08-02
Trial end
2024-12-02
Status
Recruiting
Phase
Early phase I
Treatment
Control
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Arms:
Arm1.Control
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.
Arms:
Arm2.Group Exercise, Arm3.Multi-modal Intervention
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.
Arms:
Arm3.Multi-modal Intervention
Protein Supplement
Protein supplementation will be provided.
Arms:
Arm3.Multi-modal Intervention
Vitamin D
1000 IU of oral vitamin D
Arms:
Arm1.Control, Arm2.Group Exercise, Arm3.Multi-modal Intervention
Size
324
Primary endpoint
Change in Physical Performance
Baseline and 4-months
Change in Walking Speed
Baseline and 4-months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 324, 'type': 'ESTIMATED'}}
Updated at
2023-12-28
1 organization
1 product
1 indication
Organization
McMaster UniversityIndication
frailty