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Colorectal CancerExPre 01NCT04923672

Exercise Preconditioning with Cancer Surgeries

A study testing Moderate continuous exercise and High intensity interval exercise in people with Colorectal Cancer and Hepatobiliary Cancer, run by University of Virginia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Studies have shown that people who are more physically fit prior to surgery do better after surgery. For this reason, it may be helpful for people who are going to have abdominal surgery for cancer to exercise before surgery to increase fitness. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Moderate continuous exercise and High intensity interval exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
20 Feb 2023to 12 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (≥ 18 years of age) patients undergoing elective abdominal oncologic resection of a confirmed or potential colorectal, hepatobiliary, or gynecologic neoplasm.
  • Study participants must be able to provide written informed consent and authorization.
  • Study participants must be able to understand written and verbal English, as well as to be able to communicate in English.
  • Study participants must have an Apple iphone to use during the study period

Who cannot join

  • Any patient unable and/or unwilling to cooperate with all study protocols.
  • Patients who require an assist device (walker) for ambulation.
  • Patients that indicate they did at least 3 days of vigorous intensity activity in the previous 7 days OR any combination of walking, moderate-intensity or vigorous-intensity in all of the last 7 days totaling at least 18 and a half hours
  • Recent history of cardiac disease (within 3 months of registration) that would preclude vigorous exercise
  • Individuals with end stage renal disease currently on dialysis
  • Individuals with a history of liver failure as evidenced by AST, ALT or Alkaline Phosphatase ≥ 3x upper limit of normal
Show all 14Show fewer
  • Individuals with uncontrolled hypertension
  • Women who are breastfeeding or pregnant
  • American Society of Anesthesiologists Physical Status score ≥ 4
  • Any patient that needs further cardiac evaluation per ACC/AHA perioperative criteria
  • Surgery scheduled < 3 weeks of study registration (precluding time to participate in exercise regimen)
  • Any patient who currently uses a fitness tracker or heart rate monitoring-capable device to guide exercise
  • Patient indicates a lack of familiarity or discomfort with using a smartphone
  • If participation is not in the best interest of the patient, in the opinion of the treating investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UVA Health System

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Evaluation of the Feasibility of Wearable Technology-Guided Exercise Preconditioning to Accelerate Return to Function After Cancer Surgery

Studies have shown that people who are more physically fit prior to surgery do better after surgery. For this reason, it may be helpful for people who are going to have abdominal surgery for cancer to exercise before surgery to increase fitness. In this study, patients will be assigned to either maintain their current activity, or increase activity to 5 days a week, 40 minutes per day, of either continuous moderate activity or intervals of moderate and vigorous activity (three groups). All participants will wear an Apple watch, and participants in the exercise groups will use a smartphone application to get feedback on activity and encouragement to reach activity goals.

Read the detailed description

Research indicates that people who have better physical fitness at the time of surgery have a better chance of surviving the surgery and returning to normal function. An exercise intervention in the 3+ weeks before surgery (after the decision that surgery is necessary) may help people who are going to have abdominal surgery for cancer increase fitness prior to surgery. Devices that track physical activity, like smartwatches or Fitbits, allow the wearer to get feedback on physical activity information like steps taken, distance traveled, time in light, moderate or vigorous activity and on heart rate. Having this information and using a smartphone application designed to increase physical activity may help patients increase physical activity and thereby fitness, prior to abdominal surgery for cancer.

The main goal of this project is to test two physical activity interventions and also a "control group" to make sure that participants can do the interventions and to see whether there are changes in activity and fitness in each group:

  1. Control group - maintain current activity
  2. Moderate continuous activity group - increase activity to 5 days a week, 40 minutes per day, of continuous moderate activity
  3. High Intensity Interval Training group - increase activity to 5 days a week, 40 minutes per day, of intervals of moderate and vigorous activity

All participants will wear an Apple watch, and participants in the exercise groups will use a smartphone application to get feedback on activity and encouragement to reach activity goals.

Optional: Participants will also be asked to provide a small amount of blood for research purposes.

Being tested
Moderate continuous exercise, High intensity interval exercise
Keywords
Prehabilitation, Exercise, Physical activity
Medical subject headings
Colorectal Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate continuous exerciseBehavioural

    Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of continuous moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.

  • High intensity interval exerciseBehavioural

    Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of intervals of high and moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.

Study groups in NCT04923672
Study groupRoleWhat they receive
Control groupNo interventionParticipants will be asked to wear an Apple watch through about 30 days after surgery and will be asked to maintain their current activity level.
Moderate continuous training groupActive comparatorApple watch and a smartphone application Increase activity to 5 days a week, 40 minutes a day of continuous moderate intensity exercise prior to surgery.
Receives: Behavioral: Moderate continuous exercise
High intensity interval training groupActive comparatorApple 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.
Receives: Behavioral: High intensity interval exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steps per day

    Change in average steps per day measured at baseline and at the time of surgery

    Measured: Baseline through the 1 day visit prior to surgery

Secondary outcomes (13)

  1. Enrollment rate

    Number of participants enrolled per month

    Measured: During participant accrual, estimated to take about 12 months

  2. Compliance with EXi smartphone application

    To assess feasibility of the intervention

    Measured: From baseline through 1 day visit just prior to surgery

  3. Compliance with exercise intervention, including percentage of exercise goals reached

    To assess feasibility of the intervention

    Measured: From baseline through 1 day visit just prior to surgery

  4. Completion/Dropout rate

    To assess feasibility of the intervention

    Measured: From baseline through about 30 days after surgery

  5. Percentage of time wearing Apple Watch

    To assess feasibility of the intervention

    Measured: From baseline through about 30 days after surgery

  6. Health-related quality of life

    As measured by PROMIS Global Health Scale

    Measured: Baseline and 1 day of surgery

  7. Pain intensity

    As measured by PROMIS Pain intensity

    Measured: Baseline and 1 day of surgery

  8. Pain interference

    As measured by PROMIS Pain interference

    Measured: Baseline and 1 day of surgery

  9. Physical activity level by self report

    As measured by the International Physical Activity Questionnaire

    Measured: Baseline and 1 day of surgery

  10. Surgical complications

    Based on review of medical records

    Measured: 30 days after surgery

  11. Length of hospital stay (in days) following surgery

    Days participant stayed in hospital following surgery date

    Measured: Up to 30 days following surgery

  12. Steps per day

    Measured by Apple Watch

    Measured: From baseline through 30 days after surgery

  13. Fitness level

    As measured by 6 minute walk test

    Measured: Baseline, 1 day prior to surgery, and 30, 90, and 180 days following surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start20 Feb 2023
  3. Primary completion12 Sep 2024
  4. Study completion12 Sep 2024

Why it stopped: Company providing the computer application for exercise intervention suddenly closed for business

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization to either control group or one of two exercise groups: moderate continuous or high intensity interval training
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923672
Sponsor's protocol ID
210103
Acronym
ExPre 01
Status last verified
Oct 2024
First submitted
7 Jun 2021
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Moderate continuous exercise and High intensity interval exercise in people with Colorectal Cancer and Hepatobiliary Cancer, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Company providing the computer application for exercise intervention suddenly closed for business). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps per day (time frame: Baseline through the 1 day visit prior to surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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Exercise Preconditioning with Cancer Surgeries | AzTrials