Completed

A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy

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What is being tested

Endurance

+ Strengthening

+ Stretching

Other
Who is being recruted

Myosarcoma+9

+ Neoplasms

+ Neoplasms by Histologic Type

From 6 to 30 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorSt. Jude Children's Research Hospital
Last updated: December 4, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises. Endurance exercises will consist of ambulating with assistive devices as needed, using the upper extremity (UE) ergometer, and/or playing the Wii. Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity. Resistance and exercise time will be increased depending upon participant's tolerance. Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting. PRIMARY OBJECTIVE To determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

NCT01674101
Principal SponsorSt. Jude Children's Research Hospital
Last updated: December 4, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MyosarcomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Muscle TissueSarcomaNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueRhabdomyosarcomaSarcoma, EwingOsteosarcomaSarcoma, Synovial

Criteria

9 inclusion criteria required to participate
All patients and/or their parents or legal guardians must sign a written informed consent

Lansky score >= 50 for patients age < 16

Negative pregnancy test

Participants must be between the ages of 6 and 30 years of age

Show More Criteria

3 exclusion criteria prevent from participating
Patients who do not have at least 10 weeks before receiving local control

Patients with serious, non-healing wound, ulcer or bone fracture (other than pathologic fracture)

Pre-morbid condition that prevents patient from ambulating

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises. Exercise time and resistance will be progressed per individual's medical status and per participant's tolerance. All participants will be given a tailored home exercise program (HEP). Participants will participate in PT 10 weeks prior to surgery and 10-12 weeks after surgery. Subjects will be seen by the physical therapist both when inpatient and outpatient. Patients will not be seen for PT if platelet count is less than 20,000mm3 and/or hemoglobin is less than 8g/dL.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

St. Jude Children's Research Hospital

Memphis, United StatesOpen St. Jude Children's Research Hospital in Google Maps
CompletedOne Study Center