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


N/A
6 Years
30 Years
Open (Enrolling)
Both
Osteosarcoma, Ewing's Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma, Malignant Peripheral Nerve Sheath Sarcoma, Malignant Fibrous Histiocytoma of the Bone, Chondrosarcoma of the Bone

Thank you

Trial Information

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


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.


Inclusion Criteria:



- Patient being treated at St. Jude Children's Research Hospital

- Permission from participant's physician

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

- Patient is newly diagnosed with LE malignancy as shown by biopsy. Diagnoses include:
osteosarcoma, Ewing's sarcoma, rhabdomyosarcoma, synovial sarcoma, malignant
peripheral nerve sheath sarcoma, malignant fibrous histiocytoma of the bone and
chondrosarcoma of the bone, or any other LE malignancy that requires surgical
intervention.

- Patient has Karnofsky score ≥ 50 or WHO/ECOG ≤ 2 if ≥ 16 years of age

- Lansky score ≥ 50 for patients age < 16

- Surgical intervention is planned primary mechanism of local control

- Negative pregnancy test

- All patients and/or their parents or legal guardians must sign a written informed
consent

Exclusion Criteria:

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

- Pre-morbid condition that prevents patient from ambulating

- Patients who do not have at least 10 weeks before receiving local control

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of a 10 week physical therapy intervention program

Outcome Description:

Determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen. We will consider the study to be feasible if at least 60% of the patients are able to complete at least 50% of their scheduled PT sessions.

Outcome Time Frame:

Up to 12 weeks post surgery

Safety Issue:

No

Principal Investigator

Angela M. Corr, PT, DPT

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

PTSARC

NCT ID:

NCT01674101

Start Date:

September 2012

Completion Date:

September 2015

Related Keywords:

  • Osteosarcoma
  • Ewing's Sarcoma
  • Rhabdomyosarcoma
  • Synovial Sarcoma
  • Malignant Peripheral Nerve Sheath Sarcoma
  • Malignant Fibrous Histiocytoma of the Bone
  • Chondrosarcoma of the Bone
  • Lower extremity malignancy
  • Histiocytoma
  • Neoplasms
  • Chondrosarcoma
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Synovial
  • Histiocytoma, Benign Fibrous
  • Histiocytoma, Malignant Fibrous
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794