NCT02893397

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Aug 2016Aug 2026

Study Start

First participant enrolled

August 30, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

10 years

First QC Date

August 31, 2016

Last Update Submit

March 3, 2026

Conditions

Malignant Bone Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Feasibility defined as at least 10 of out 15 patients in the supervised exercise group complete more than or equal to 75% (9 of 12 sessions) supervised physical therapy exercise sessions

    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.

    At least 4 weeks

Secondary Outcomes (2)

  • Change in tumor vascularity as measured by magnetic resonance imaging diffusion studies

    Baseline up to 4 weeks

  • Change in tumor vascularity as measured by blood serum analysis of serum thrombospondin-1 and sphingosine-1-phosphate

    Baseline up to 4 weeks

Study Arms (2)

Group I (supervised exercise)

EXPERIMENTAL

Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.

Behavioral: Exercise Intervention

Group II (fitbit)

EXPERIMENTAL

Patients wear a fitbit.

Device: Activity Monitor

Interventions

Activity MonitorDEVICE

Wear a fitbit

Also known as: Activity Tracker, Activity Tracker Device, Physical Activity Measuring Device
Group II (fitbit)
Exercise InterventionBEHAVIORAL

Undergo supervised exercise sessions

Group I (supervised exercise)

Eligibility Criteria

Age5 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have a new diagnosis of primary bone tumor, and whose treatment plan includes surgery
  • Patients who are expected to receive at least 4 weeks of neoadjuvant chemotherapy treatment between enrollment in the study and planned surgery
  • Participants willing to wear a Fitbit

You may not qualify if:

  • Patients who are not receiving their primary cancer care (surgery and chemotherapy) at MD Anderson Cancer Center (participants from the supervised exercise group only)
  • Patients who have a cognitive disorder which impacts the ability to follow directions or adhere to safety rules; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
  • Patients who have a neurological or structural disorder which would impact use of exercise equipment; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising
  • Any patient who, in the opinion of the investigators, will be unable to comply with a supervised exercise regimen
  • Any concurrent co-morbid illness and/or infection which in the opinion of the investigators could make the patient unable to comply fully with the trial procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Valerae O Lewis

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 8, 2016

Study Start

August 30, 2016

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(2)