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Exercise and Nutrition Prehabilitation for Frailty (PREVENT Trial)
N/A
Waitlist Available
Led By Atilio Barbeito, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 50 years
Scheduled for high-risk surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PREVENT Trial Summary
This trial will test an intervention to help patients before high-risk surgery by combining medical care with state-of-the-art nutritional support and other innovations. The goal is to reduce complications and hospital readmissions, and to improve quality of life for Veterans.
Who is the study for?
This trial is for Veterans aged 50 or older who are English-speaking and scheduled for high-risk surgery with at least 21 days before the operation. They must have certain scores on physical function tests indicating frailty. Those with severe cognitive impairment, dementia, extreme surgical risk (ASA categories 4 and 5), living in skilled nursing facilities, without phone access, or advanced kidney disease cannot participate.Check my eligibility
What is being tested?
The study is testing a pre-surgery 'prehabilitation' program that includes supervised exercise (aerobic + resistance training) and nutritional support. It aims to improve recovery outcomes using telehealth services and activity trackers to help Veterans prepare physically for their upcoming surgeries.See study design
What are the potential side effects?
While specific side effects are not detailed here, exercise programs may cause muscle soreness or injury if not done correctly. Nutritional interventions could potentially lead to digestive changes depending on the individual's condition.
PREVENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I am scheduled for a surgery that carries high risks.
Select...
My 5RSTS time is over 11 seconds or my TMST score is in the bottom 25% for my age/gender.
PREVENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability, measured as compliance rate
Feasibility, measured as acceptance rate
Reasons for enrollment/non-enrollment
+1 moreSecondary outcome measures
Anxiety and Depression
Physical function - Aerobic endurance
Physical function - Lower extremity strength and balance
+1 morePREVENT Trial Design
1Treatment groups
Experimental Treatment
Group I: PrehabilitationExperimental Treatment1 Intervention
This pilot cohort will undergo an intervention and will be followed for up to 6 months. The study does not include a comparator group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supervised aerobic + resistance training and nutritional support
2021
N/A
~20
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,612 Previous Clinical Trials
3,305,723 Total Patients Enrolled
9 Trials studying Frailty
30,844 Patients Enrolled for Frailty
Duke UniversityOTHER
2,365 Previous Clinical Trials
3,420,620 Total Patients Enrolled
2 Trials studying Frailty
812 Patients Enrolled for Frailty
Atilio Barbeito, MDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.I am scheduled for a surgery that carries high risks.My surgery is scheduled within 21 days from my last assessment.My kidney function is severely reduced.My 5RSTS time is over 11 seconds or my TMST score is in the bottom 25% for my age/gender.I have been diagnosed with dementia.I cannot complete physical function tests.
Research Study Groups:
This trial has the following groups:- Group 1: Prehabilitation
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.
Can you provide a count of the participants in this experiment?
"Affirmative. Data located on clinicaltrials.gov reveals that the medical study, which was initially posted on May 27th 2021, is currently enrolling individuals. 24 participants will be enrolled from a single site."
Answered by AI
Are any openings still available for participants in this research?
"Indeed, clinicaltrials.gov confirms that this trial is actively looking for 24 individuals to participate from 1 medical site. This research project was first posted on May 27th 2021 and last updated on September 2nd 2022."
Answered by AI
What are the aims of this research endeavor?
"This 24-week clinical trial will be assessing the acceptability of this medical intervention, as measured by compliance rate. Secondary objectives include evaluating changes in anxiety and depression (using HADS questionnaires), physical function strength and balance (through 5XSST tests) and quality of life (utilizing SF-36 surveys)."
Answered by AI
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