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Pre-Surgery Exercise for Frailty
Ottawa, Canada
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
Must not have
Palliative surgery
Inability to communicate in English or in French
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
No Placebo-Only Group
Summary
This trial will compare the effects of a home-based exercise program to no exercise program in people who have had surgery.
See full description
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 belowSelect...
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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Select...
I am considered frail based on a clinical assessment.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery to relieve symptoms.
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Select...
I cannot communicate in English or French.
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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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
In-hospital complications
Patient-reported disability 30 days after surgery
Secondary study objectives
All-cause mortality
Function - 5 Times Sit to Stand
Function - Daily and total step count
+9 moreSide effects data
From 2009 Phase 1 & 2 trial • 152 Patients • NCT008157767%
Discomfort or Pain
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clayton Intra-aural Device (CID) Group
Mouth Splint Group
Jaw Exercise Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1020
Find a Location
Closest Location:The Ottawa Hospital· Ottawa, Canada· 743 miles
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
580 Previous Clinical Trials
3,206,852 Total Patients Enrolled
6 Trials studying Frailty
663,025 Patients Enrolled for Frailty
Daniel I McIsaac, MD,MPH,FRCPCPrincipal InvestigatorThe Ottawa Hospital Research Institute
1 Previous Clinical Trials
413 Total Patients Enrolled
1 Trials studying Frailty
413 Patients Enrolled for Frailty
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to relieve symptoms.My surgery is scheduled between 3 to 12 weeks from now.I cannot communicate in English or French.I have had heart, brain, or bone surgery.I am scheduled for surgery that will require me to stay in the hospital for at least 2 days.I am 60 years old or older.I am considered frail based on a clinical assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Exercise Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.