Exercise Intervention Prior to CRS-HIPEC: Feasibility & Impact
NCT ID: NCT04731441
Last Updated: 2024-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2021-03-18
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
After randomization, subjects will proceed with a baseline assessment to obtain basic demographics, muscle strength, endurance performance, physical functioning, and physical activity. The subject will then proceed with 6 weeks of participating in the control or intervention arm, followed by surgery and a post-operative assessment. After the post-operative assessment, study is complete.
TREATMENT
NONE
Study Groups
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Exercise Group
Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
Home-based Exercise Program Prior to CRS-HIPEC
Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
Education Group
Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC. Results and outcomes will not be recorded.
Exercise Education
Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.
Interventions
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Home-based Exercise Program Prior to CRS-HIPEC
Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
Exercise Education
Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.
Eligibility Criteria
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Inclusion Criteria
* Patients should be eligible for and consent to surgery with the intention of performing CRS / HIPEC at Penn State Hershey Medical Center. Eligibility for CRS/HIPEC is a clinical determination based on a combination of factors including radiographic extent of disease, tumor histology and medical fitness for surgery
* Subjects who are explored but found to be unresectable will be included.
* Male or female.
* Patients should be age 18 or above.
* Surgery is planned for not less than 6 weeks and no more than 10 weeks from consultation
Exclusion Criteria
* Patients who require urgent surgery, sooner than 6 weeks
* Patients receiving neoadjuvant chemotherapy, with no surgical date planned before 10 weeks from consultation. These patients can be enrolled at the time of the follow-up visit, as long as they meet above criteria
* Patients not fluent in English
* Pregnant women
* Prisoners
* Patients with Cognitive Impairment
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Colette Pameijer
Professor, Department of Surgery
Principal Investigators
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Colette R Pameijer, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Locations
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Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY00015358
Identifier Type: -
Identifier Source: org_study_id
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