LCI-PED-NOS-EXER-001: Exercise in Pediatric Oncology Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to see if there are physical and emotional benefits to participating in a structured exercise regimen for those who are ages 2-25, are newly diagnosed with a blood or solid tumor cancer, and are currently undergoing or will begin cancer treatment.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This is a randomized, controlled trial to investigate if a structured exercise regimen will have benefit relative to the control arm by increasing and /or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test and BOT-2 Brief or PDMS-2.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EXER "Just Move" exercises |
Other: "Just Move" Exercise
Subjects complete "Just Move" Exercises Five Times Per Week
|
Experimental: SOC EXER Standard of Care Exercise |
Other: Standard of Care Exercise
Subjects exercise/move as tolerated
|
Outcome Measures
Primary Outcome Measures
- Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [18 month period]
Investigate if 20 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by 6-Minute Walk test
- Potential benefit of increasing/maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment [18 month period]
Investigate if 20 minutes of exercise, five days per week, will have benefit relative to the control arm by increasing and/or maintaining physical functioning in pediatric subjects undergoing chemotherapy and childhood cancer treatment as measured by BOT-2 Brief (in subjects ≥ 4 years of age) or PDMS-2 (in subjects < 4 years of age).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 2-25 at time of consent
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Subject has newly diagnosed cancer per Investigator, and is planning to undergo chemotherapy for treatment of malignancy
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Ability of subject (and/or parent/guardian) to read and understand the English or Spanish language
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Subject is anticipated to receive at least 3 months of chemotherapy or other cancer treatment.
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As determined and documented by the enrolling investigator, ability of the subject to understand and comply with study procedures for the entire length of the study
Exclusion Criteria:
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Known cardiac dysfunction that, in the opinion of the investigator, would be unsafe for the child to participate in the exercise program
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Recent (within 4 weeks of enrollment) or planned surgery that will result in prolonged limited mobility not amendable to exercise modifications per investigator discretion
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Primary CNS Tumor
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Osteosarcoma
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Levine Children's Hospital | Charlotte | North Carolina | United States | 28203 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Jamie Mochel, MSN, CPNP-AC, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00082746
- LCI-PED-NOS-EXER-001