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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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I am receiving care focused on relieving symptoms and improving my quality of life.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-months and additional 6-month follow-up

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Group Exercise

2019

Completed Phase 3

~70

Protein Supplement

2009

Completed Phase 3

~5380