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Frailty Rehabilitation for Older Adults with Frailty

Phase 4
Recruiting
Led By Alexandra Papaioannou, MD, MSc
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to independently ambulate 25m with or without walking aid
Be older than 65 years old
Must not have
Unstable angina or heart failure
Receiving palliative/end of life care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-months and additional 6-month follow-up
Awards & highlights

Summary

This trial will investigate whether a frailty rehabilitation program can improve physical function in older adults living with frailty and sarcopenia.

Who is the study for?
This trial is for community-dwelling adults over 65 who can walk 25m with/without aid, have medical clearance, and can get to the YMCA twice a week. They must be fully vaccinated against COVID-19 and at high risk for mobility issues but not in palliative care or other specific health programs.
What is being tested?
The study tests if a 4-month frailty rehabilitation program improves physical function in older adults with frailty and sarcopenia compared to control groups receiving only exercise or no intervention. It includes nutrition, medication review, vitamin D supplements, group exercises, and protein supplements.
What are the potential side effects?
Potential side effects may include discomfort from exercise routines or reactions to nutritional supplements like vitamin D or proteins. However, specifics aren't provided; it's generally expected that interventions are low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk 25 meters by myself, with or without help from a walking aid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have unstable chest pain or heart failure.
Select...
I am receiving care focused on relieving symptoms and improving my quality of life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-months and additional 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-months and additional 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Physical Performance
Change in Walking Speed
Secondary study objectives
Change in Balance Confidence
Change in Basic Activities of Daily Living
Change in Cognition
+16 more
Other study objectives
Individual-level Economic Evaluation

Side effects data

From 2015 Phase 3 trial • 486 Patients • NCT02014467
7%
Arthralgia
5%
Blood cholesterol increased
1%
Any event
1%
Femoral neck fracture
1%
Bone density decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab 60mg
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm3.Multi-modal InterventionExperimental Treatment4 Interventions
Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented.
Group II: Arm2.Group ExerciseExperimental Treatment2 Interventions
Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise.
Group III: Arm1.ControlExperimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Protein Supplement
2009
Completed Phase 3
~5380
Group Exercise
2019
Completed Phase 3
~70
Vitamin D
2013
Completed Phase 4
~3670

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,612,917 Total Patients Enrolled
9 Trials studying Frailty
3,055 Patients Enrolled for Frailty
Alexandra Papaioannou, MD, MScPrincipal InvestigatorMcMaster University
7 Previous Clinical Trials
10,062 Total Patients Enrolled
1 Trials studying Frailty
70 Patients Enrolled for Frailty

Media Library

Frailty Clinical Trial 2023: Group Exercise Highlights & Side Effects. Trial Name: NCT03824106 — Phase 4
Group Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824106 — Phase 4
~108 spots leftby Sep 2025
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