Clinical trial NCT03824106: Frailty Rehabilitation
Official title: Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 324
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Physical Performance
timeFrame: Baseline and 4-months
measure: Change in Walking Speed
timeFrame: Baseline and 4-months
Secondary outcomes:
measure: Change in Frailty
timeFrame: Baseline and 4-months
measure: Change in Fear of Falling
timeFrame: Baseline and 4-months
measure: Change in Balance Confidence
timeFrame: Baseline and 4-months
measure: Change in Falls
timeFrame: Baseline and 4-months
measure: Change in Fitness
timeFrame: Baseline and 4-months
measure: Change in Strength
timeFrame: Baseline and 4-months
measure: Change in Functional Mobility
timeFrame: Baseline and 4-months
measure: Change in Cognition
timeFrame: Baseline and 4-months
measure: Change in Cognition
timeFrame: Baseline and 4-months
measure: Change in Health-related Quality of Life
timeFrame: Baseline and 4-months
measure: Change in Life Space Mobility
timeFrame: Baseline and 4-months
measure: Change in Basic Activities of Daily Living
timeFrame: Baseline and 4-months
measure: Change in Instrumental Activities of Daily Living
timeFrame: Baseline and 4-months
measure: Change in Depression / Mood
timeFrame: Baseline and 4-months
measure: Change in Nutrition
timeFrame: Baseline and 4-months
measure: Change in Sarcopenia
timeFrame: Baseline and 4-months
measure: Change in Muscle Mass
timeFrame: Baseline and 4-months
measure: Change in Emergency Room Visits
timeFrame: Baseline, 4-months and additional 6-month follow-up
measure: Change in Hospitalizations
timeFrame: Baseline, 4-months and additional 6-month follow-up
measure: Change in Institutionalization
timeFrame: Baseline, 4-months and additional 6-month follow-up
Other outcomes:
measure: Individual-level Economic Evaluation
timeFrame: Baseline, 4-months and additional 6-month follow-up
Locations:
city: Hamilton
country: Canada
facility: McMaster University - St. Peter's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Alexandra Papaioannou, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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