Activity monitor
DeviceWear a fitbit
Other names: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
NCT Number: NCT02893397
This clinical trial studies how well supervised exercise works in improving physical fitness before surgery in patients with bone cancer that can be removed by surgery. Supervised exercise may provide better short-term physical fitness in patients with bone cancer.
This study is active but is not currently recruiting participants.
Notify Me5 year–39 year
All sexes
Interventional
Not applicable
M D Anderson Cancer Center, Houston, Texas, United States
PRIMARY OBJECTIVES:
I. To determine if regular exercise, which may improve delivery and efficacy of chemotherapy, is feasible in children and young adults with malignant bone tumors undergoing neoadjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To determine if exercise results in a change in tumor vascularity as evidenced by magnetic resonance imaging (MRI) in children and young adults with malignant bone tumors who participate in structured aerobic exercise as compared to children and young adults who do not.
II. To determine whether serum levels of thrombospondin-1, an endogenous anti-angiogenic protein, and sphingosine-1-phosphate, an angiogenic modulator, increase in children and young adults with malignant bone tumors who participate in supervised aerobic exercise over a 4 week period of time during neoadjuvant chemotherapy.
III. To determine if aerobic exercise decreases reactive oxygen species (ROS) in the peripheral blood of bone sarcoma patients.
IV. To determine if the numbers of circulating tumor cells decrease in patients who participate in supervised exercise over a 4 week period of time.
V. To determine whether a home-based exercise program or supervised exercise program is more feasible for this patient population.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.
GROUP II: Patients wear a fitbit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Wear a fitbit
Other names: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
Undergo supervised exercise sessions
Time frame: At least 4 weeks
Completion of daily exercise is defined as at least 20 minutes of aerobic exercise achieved within heart rate and blood pressure that the licensed physical therapist has determined is safe for the patient on that given day.
Time frame: Baseline up to 4 weeks
Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
Time frame: Baseline up to 4 weeks
Will use a two-sided t-test with a significance level of 5% to compare the tumor vascularity between groups.
M.D. Anderson Cancer Center
Other
Pre-Surgical Supervised Exercise for Bone Cancer Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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