Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

St. Jude Children's Research Hospital

Status: Completed

Conditions: Osteosarcoma; Rhabdomyosarcoma; Ewing's Sarcoma; Malignant Fibrous Histiocytoma of the Bone; Malignant Peripheral Nerve Sheath Sarcoma; Synovial Sarcoma; Chondrosarcoma of the Bone

Treatments: Other: Endurance; Other: Strengthening; Other: Home exercise program; Other: Stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT01674101

NCI-2012-01920 (Registry Identifier)

TPTA (YR 1) (Other Identifier)

PTSARC

Details and patient eligibility

About

This application proposes a prospective clinical trial to evaluate the impact of adding a focused physical therapy (PT) intervention to the preoperative regimen of individuals diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Physical Therapy

Experimental group

Description:

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.

Treatment:

Other: Stretching

Other: Home exercise program

Other: Strengthening

Other: Endurance