Frailty Rehabilitation

McMaster University

Status: Enrolling

Conditions: Frailty

Treatments: Other: Control; Combination Product: Nutrition and Medication review; Behavioral: Group Exercise; Dietary Supplement: Vitamin D; Dietary Supplement: Protein Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03824106

5500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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324 participants in 3 patient groups

Arm1.Control

Experimental group

Description:

Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D.

Treatment:

Dietary Supplement: Vitamin D

Other: Control

Arm2.Group Exercise

Experimental group

Description:

Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.

Treatment:

Dietary Supplement: Vitamin D

Behavioral: Group Exercise

Arm3.Multi-modal Intervention

Experimental group

Description:

Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented.

Treatment:

Dietary Supplement: Protein Supplement

Dietary Supplement: Vitamin D

Combination Product: Nutrition and Medication review

Behavioral: Group Exercise