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Pre-Surgery Exercise for Cancer (ExPre 01 Trial)

N/A

Waitlist Available

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

Must not have

Individuals with uncontrolled hypertension

American Society of Anesthesiologists Physical Status score ≥ 4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during participant accrual, estimated to take about 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I can understand and communicate in English.

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I am an adult scheduled for surgery on my abdomen for cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My high blood pressure is not under control.

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My health is severely limited by my illness.

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I need a walker to help me move around.

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I am on dialysis for end-stage kidney disease.

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I am not pregnant or breastfeeding.

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My liver tests are three times above the normal range.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during participant accrual, estimated to take about 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Completion/Dropout rate

Compliance with EXi smartphone application

Compliance with exercise intervention, including percentage of exercise goals reached

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met