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Pre-Surgery Exercise for Cancer (ExPre 01 Trial)
N/A
Recruiting
Led By Traci Hedrick, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study participants must be able to understand written and verbal English, as well as to be able to communicate in English
Adult (≥ 18 years of age) patients undergoing elective abdominal oncologic resection of a confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during participant accrual, estimated to take about 12 months
Awards & highlights
ExPre 01 Trial Summary
This trial will test whether exercising before surgery can improve outcomes. Patients will be assigned to different exercise regimens, with all participants wearing an Apple watch to track activity.
Who is the study for?
This trial is for adults (18+) scheduled for elective abdominal cancer surgery who own an iPhone, can consent and communicate in English. Excluded are those already very active, with recent heart issues, liver failure, kidney disease on dialysis, pregnant/breastfeeding women, high anesthesia risk patients or anyone uncomfortable using smartphones.Check my eligibility
What is being tested?
The study tests if pre-surgery exercise improves recovery. Participants will either maintain their usual activity or increase it to five days a week of moderate continuous exercise or intervals of moderate/vigorous activity. Progress is tracked via Apple Watch and a smartphone app.See study design
What are the potential side effects?
Since the interventions involve physical exercise, potential side effects may include muscle soreness, fatigue, joint pain or injury. However specific risks depend on individual health status and intensity of exercises performed.
ExPre 01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and communicate in English.
Select...
I am an adult scheduled for surgery on my abdomen for cancer treatment.
ExPre 01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during participant accrual, estimated to take about 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during participant accrual, estimated to take about 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Completion/Dropout rate
Compliance with EXi smartphone application
Compliance with exercise intervention, including percentage of exercise goals reached
+10 moreExPre 01 Trial Design
3Treatment groups
Active Control
Group I: Moderate continuous training groupActive Control1 Intervention
Apple watch and a smartphone application
Increase activity to 5 days a week, 40 minutes a day of continuous moderate intensity exercise prior to surgery.
Group II: High intensity interval training groupActive Control1 Intervention
Apple watch and a smartphone application
Increase activity to 5 days a week, 40 minutes a day of intervals of high and moderate intensity exercise prior to surgery.
Group III: Control groupActive Control1 Intervention
Participants will be asked to wear an Apple watch through about 30 days after surgery and will be asked to maintain their current activity level.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
754 Previous Clinical Trials
1,245,016 Total Patients Enrolled
Traci Hedrick, MDPrincipal InvestigatorUVA
2 Previous Clinical Trials
35 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and communicate in English.I have had heart problems in the last 3 months that stop me from doing hard exercise.My high blood pressure is not under control.My health is severely limited by my illness.I need a walker to help me move around.I am on dialysis for end-stage kidney disease.I am not pregnant or breastfeeding.My surgery is scheduled in less than 3 weeks from now.I am willing and able to follow all study requirements.My liver tests are three times above the normal range.I am an adult scheduled for surgery on my abdomen for cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Moderate continuous training group
- Group 2: High intensity interval training group
- Group 3: Control 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently opportunities to take part in this trial?
"Data published on clinicaltrials.gov suggests that this medical trial is still recruiting participants. It was first posted to the website on June 1st 2022 and its information has been updated as recently as May 23rd 2022."
Answered by AI
How many participants are anticipated to join this experiment?
"Affirmative. Clinicaltrials.gov contains information that this medical trial is actively enlisting participants, with the initial post dating back to June 1st 2022 and the most recent edit occurring on May 23rd of 2022. 57 individuals are expected to take part in two distinct locations."
Answered by AI
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