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Pre-Surgery Exercise for Frailty

N/A

Waitlist Available

Led By Daniel I McIsaac, MD,MPH,FRCPC

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elective surgery with expected post-surgery stay of 2 days or more.

60 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants are asked to reflect on the program during a call the day before surgery.

Awards & highlights

Study Summary

This trial will compare the effects of a home-based exercise program to no exercise program in people who have had surgery.

Who is the study for?

This trial is for people aged 60 or older who are considered frail (with a Clinical Frailty Scale score of at least 4/9) and have elective surgery planned that will require a hospital stay of two days or more. They must be able to start the exercise program between 3 and 12 weeks before their surgery date. Those with certain heart, nerve, or bone conditions, unable to communicate in English or French, having palliative surgeries, or unreachable by phone cannot join.Check my eligibility

What is being tested?

The PREPARE Trial is testing if doing exercises at home before surgery can help reduce complications and disability after surgery in older adults with frailty. Participants are split into two groups randomly: one group follows the exercise program while the other does not.See study design

What are the potential side effects?

Since this trial involves an exercise regimen rather than medication, side effects may include typical risks associated with physical activity such as muscle soreness, fatigue, and increased risk of falls or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery that will require me to stay in the hospital for at least 2 days.

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I am 60 years old or older.

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I am considered frail based on a clinical assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessing the difference in the occurrence of falls between the exercise group and control group on day 3, 5, 7, up to 30 days, as well as 30-day, 90-day and one-year after surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessing the difference in the occurrence of falls between the exercise group and control group on day 3, 5, 7, up to 30 days, as well as 30-day, 90-day and one-year after surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessing the difference in the occurrence of falls between the exercise group and control group on day 3, 5, 7, up to 30 days, as well as 30-day, 90-day and one-year after surgery. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

In-hospital complications

Patient-reported disability 30 days after surgery

Secondary outcome measures

All-cause mortality

Function - 5 Times Sit to Stand

Function - Daily and total step count

+9 more

Side effects data

From 2009 Phase 1 & 2 trial • 152 Patients • NCT00815776

Discomfort or Pain

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Clayton Intra-aural Device (CID) Group

Mouth Splint Group

Jaw Exercise Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exercise GroupExperimental Treatment1 Intervention

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.

Group II: Control GroupActive Control1 Intervention

The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Group

2022

Completed Phase 3

~930

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,784,841 Total Patients Enrolled

4 Trials studying Frailty

350,324 Patients Enrolled for Frailty

Daniel I McIsaac, MD,MPH,FRCPCPrincipal InvestigatorThe Ottawa Hospital Research Institute

Media Library

Exercise Group Clinical Trial Eligibility Overview. Trial Name: NCT04221295 — N/A

Frailty Research Study Groups: Control Group, Exercise Group

Frailty Clinical Trial 2023: Exercise Group Highlights & Side Effects. Trial Name: NCT04221295 — N/A

Exercise Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04221295 — N/A

Frequently Asked Questions

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

What is the intended outcome of this investigation?

"This research endeavour aims to gauge patient disability levels after 30 days of post-operative recovery. Additional objectives include surveying mortality rates, safety (adverse events) and health system discharge position. Falls, cardiac or respiratory issues and unplanned healthcare providence will be monitored for the exercise group while control participants must report any falls from enrollment onwards. Unforeseen medical experiences are also scrutinised during enrolment to pre-operation day in the intervention cohort via chart analysis."

Answered by AI

Are there any limitations on the number of participants in this observational research?

"Indeed, the information available on clinicaltrials.gov reveals that this experiment is recruiting participants currently; it was initially posted on February 24th 2020 and its details were last modified at the end of November 2022. This trial seeks out 750 individuals from a single medical facility."

Answered by AI

Is enrollment for this trial still open to new applicants?

"Affirmative, the clinicaltrials.gov website states that recruitment is ongoing for this medical trial. It was first listed on February 24th 2020 and most recently edited on November 29th 2022 with a goal of enrolling 750 patients at 1 site."

Answered by AI

Recent research and studies

BMJ OpenJournal

PREPARE Trial: A Protocol for a Multicentre Randomised Trial of Frailty-focused Preoperative Exercise to Decrease Postoperative Complication Rates and Disability Scores

McIsaac, Daniel I, Dean A Fergusson, Rachel Khadaroo, Amanda Meliambro, John Muscedere, Chelsia Gillis, Emily Hladkowicz, and Monica Taljaard. 2022. “PREPARE Trial: A Protocol for a Multicentre Randomised Trial of Frailty-focused Preoperative Exercise to Decrease Postoperative Complication Rates and Disability Scores”. BMJ Open. BMJ. doi:10.1136/bmjopen-2022-064165.

clinicaltrials.govStudy

The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

2020. "The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04221295.