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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can walk 25 meters by myself, with or without help from a walking aid.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Physical Performance

Change in Walking Speed

Secondary outcome measures

Change in Balance Confidence

Change in Basic Activities of Daily Living

Change in Cognition

+16 more

Other outcome measures

Individual-level Economic Evaluation

Side effects data

From 2015 Phase 3 trial • 486 Patients • NCT02014467

Arthralgia

Blood cholesterol increased

Any event

Femoral neck fracture

Bone density decreased

100%

80%

60%

40%

20%

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

Vitamin D

2013

Completed Phase 4

~3470

Group Exercise

2019

Completed Phase 3

~70

Protein Supplement

2009

Completed Phase 3

~5380

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,562 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide the upper limit on how many people are taking part in this trial?

"Affirmative. The information found on clinicaltrials.gov confirms that the research is still open to recruitment, with an initial post date of September 2nd 2022 and a recent amendment done on September 3rd 2022. This experiment seeks 324 volunteers from 1 location."

Answered by AI

What are the primary aims of this research endeavor?

"This clinical trial, lasting for a baseline period plus 4 months, is intended to measure Change in Walking Speed. The secondary objectives include the assessment of Change in Hospitalizations (quantified by number of hospital visits), Change in Cognition as determined by Mini-Mental State Examination scores [0-30], and Changes in Instrumental Activities of Daily Living which are measured through Lawton's questionnaire [range 0-8]."

Answered by AI

Is enrollment for this trial currently available to the public?

"According to the information hosted on clinicaltrials.gov, this trial is presently open for volunteers and was first published on September 2nd 2022 with edits most recently made on September 3rd of that same year."

Answered by AI

Has the FDA sanctioned Nutrition and Medication review?

"As this treatment is approved, we at Power rate its safety as 3 on a scale of 1 to 3. This Phase 4 trial indicates that the medication and nutrition review has been deemed safe for use."

Answered by AI

Recent research and studies

Osteoporosis InternationalJournal

A Frailty Index Predicts 10-year Fracture Risk in Adults Age 25 Years and Older: Results from the Canadian Multicentre Osteoporosis Study (camos)

Kennedy, C. C., G. Ioannidis, K. Rockwood, L. Thabane, J. D. Adachi, S. Kirkland, L. E. Pickard, and A. Papaioannou. 2014. “A Frailty Index Predicts 10-year Fracture Risk in Adults Age 25 Years and Older: Results from the Canadian Multicentre Osteoporosis Study (camos)”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s00198-014-2828-9.

Canadian Medical Association JournalJournal

Changes in Relative Fitness and Frailty Across the Adult Lifespan: Evidence from the Canadian National Population Health Survey

Rockwood, K., X. Song, and A. Mitnitski. 2011. “Changes in Relative Fitness and Frailty Across the Adult Lifespan: Evidence from the Canadian National Population Health Survey”. Canadian Medical Association Journal. CMA Joule Inc.. doi:10.1503/cmaj.101271.

British Journal of Sports MedicineJournal

Exercise to Prevent Falls in Older Adults: An Updated Systematic Review and Meta-analysis

Sherrington, Catherine, Zoe A Michaleff, Nicola Fairhall, Serene S Paul, Anne Tiedemann, Julie Whitney, Robert G Cumming, Robert D Herbert, Jacqueline C T Close, and Stephen R Lord. 2016. “Exercise to Prevent Falls in Older Adults: An Updated Systematic Review and Meta-analysis”. British Journal of Sports Medicine. BMJ. doi:10.1136/bjsports-2016-096547.

BMC MedicineJournal