Frailty Rehabilitation

NCT03824106 | Recruiting DMC

• 1 other identifier: 5500
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Physical Performance

  Physical function will be assessed with the Short Performance Physical Battery \[total score\]. Higher scores indicate better physical performance \[range 0-12\].

  Baseline and 4-months

• Change in Walking Speed

  Walking speed will be assessed with the 400-m Walk Test \[walking speed, m/s\]. Faster walking speeds indicate better performance.

  Baseline and 4-months

Secondary Outcomes (20)

• Change in Frailty

  Baseline and 4-months

• Change in Fear of Falling

  Baseline and 4-months

• Change in Balance Confidence

  Baseline and 4-months

• Change in Falls

  Baseline and 4-months

• Change in Fitness

  Baseline and 4-months

Other Outcomes (1)

• Individual-level Economic Evaluation

  Baseline, 4-months and additional 6-month follow-up

Study Arms (3)

Arm1.Control

EXPERIMENTAL

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

Other: Control; Dietary Supplement: Vitamin D

Arm2.Group Exercise

EXPERIMENTAL

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

Behavioral: Group Exercise; Dietary Supplement: Vitamin D

Arm3.Multi-modal Intervention

EXPERIMENTAL

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

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

Interventions

Control OTHER

Participants randomized to the control arm will not receive any of the Frailty Management Interventions.

Arm1.Control

Group Exercise BEHAVIORAL

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.

Arm2.Group Exercise; Arm3.Multi-modal Intervention

Nutrition and Medication review COMBINATION_PRODUCT

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.

Arm3.Multi-modal Intervention

Protein Supplement DIETARY_SUPPLEMENT

Protein supplementation will be provided.

Arm3.Multi-modal Intervention

Vitamin D DIETARY_SUPPLEMENT

1000 IU of oral vitamin D

Arm1.Control; Arm2.Group Exercise; Arm3.Multi-modal Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University - St. Peter's Hospital

Hamilton, Ontario, L8M1W9, Canada

RECRUITING

Related Publications (53)

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MeSH Terms

Conditions

Frailty

Interventions

Nutritional Status; Medication Review; Vitamin D

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alexandra Papaioannou, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherri Smith

CONTACT

905 521 2100; smithsher@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 31, 2019
• Study Start: September 2, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 6, 2025

Record last verified: 2024-11

Locations

CA (1)