Recruiting

Frailty Rehabilitation

Sponsor:

McMaster University

Code:

NCT03824106

Conditions

Frailty

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Control

Group Exercise

Nutrition and Medication review

Protein Supplement

Vitamin D

Study Details

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.

Conditions

Frailty

Study ID

NCT03824106

Start date

Sep 2, 2022

Status verified date

Nov, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm1.Control

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

experimental: Arm2.Group Exercise

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

experimental: Arm3.Multi-modal Intervention

Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.

Nutrition, protein supplementation, and a medication review will also be implemented.

Interventions

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

Primary outcome measure

  • Change in Physical Performance [ Time Frame: Baseline and 4-months ]
  • Change in Walking Speed [ Time Frame: Baseline and 4-months ]

Central Contacts and Locations

Central contacts

Locations

McMaster University - St. Peter's Hospital

Recruiting

Hamilton, Ontario, Canada, L8M1W9

Contacts

Principal Investigator:

Alexandra Papaioannou, MD, MSc

More Information

Sponsor

McMaster University

Last update posted

Jul 6, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2025-07-06.