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Behavioural Intervention
Prehabilitation Exercise Program for Frailty
Phase 1
Waitlist Available
Led By Victor Ezeugwu, PhD
Research Sponsored by Victor Ezeugwu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
50 years of age or older
Score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale (CFS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
Study Summary
This trial studies whether prehabilitation (exercise/reducing sedentary behavior) can help reduce complications, hospital stays, and recovery times for people who are vulnerable or frail before surgery.
Who is the study for?
This trial is for people aged 50 or older who are scheduled for elective surgery and have been identified as vulnerable or mildly/moderately frail based on a clinical scale. They must be able to walk, with or without aids. Those with unstable medical conditions that limit exercise tolerance cannot participate.Check my eligibility
What is being tested?
The study tests if a pre-surgery program combining strength training exercises and activities aimed at reducing sitting time can decrease complications, shorten hospital stays, and speed up recovery in patients undergoing elective surgery.See study design
What are the potential side effects?
While the intervention focuses on exercise which typically has benefits like improved strength and mobility, potential side effects may include muscle soreness, fatigue, and an increased risk of falls or injury during the training period.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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I am somewhat frail but not completely dependent on others for daily activities.
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I am scheduled for a planned surgery.
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I can walk by myself or with help like a cane or walker.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline gait speed at 12 and 24 weeks
Secondary outcome measures
Change from baseline Barthel Index at 12 and 24 weeks
Change from baseline Saint Louis University mental status (SLUMS) test
Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.
Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
Group II: Standard of careActive Control1 Intervention
The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation.
Find a Location
Who is running the clinical trial?
Royal Alexandra HospitalOTHER
17 Previous Clinical Trials
7,878 Total Patients Enrolled
Victor EzeugwuLead Sponsor
Victor Ezeugwu, PhDPrincipal InvestigatorUniversity of Alberta
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk by myself or with help like a cane or walker.I am scheduled for a planned surgery.I am somewhat frail but not completely dependent on others for daily activities.I am 50 years old or older.I have a condition like ME/CFS that makes it hard for me to exercise.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental
- Group 2: Standard of care
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Experimental achieved authorization from the FDA?
"The risk profile for Experimental in this early-stage clinical trial is rated as a 1 due to the paucity of data validating its safety and efficacy."
Answered by AI
Are there any available vacancies for participants in this research trial?
"Reports on clinicaltrials.gov confirm that the medical trial, initiated on September 1st 2023, is not currently recruiting patients. However, there are 160 other studies seeking candidates at this time."
Answered by AI
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