Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

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

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.

Study Overview

• Status: Completed
• Conditions: Osteosarcoma; Rhabdomyosarcoma; Synovial Sarcoma; Ewing's Sarcoma; Malignant Peripheral Nerve Sheath Sarcoma; Malignant Fibrous Histiocytoma of the Bone; Chondrosarcoma of the Bone
• Intervention / Treatment: Other: Endurance; Other: Strengthening; Other: Stretching; Other: Home exercise program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children'S Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Physical Therapy; 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.

Other: Endurance; Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.; Other Names: Physical therapy; Other: Strengthening; 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.; Other Names: Physical therapy; Other: Stretching; 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.; Other Names: Physical therapy; Other: Home exercise program; All participants will be given a tailored home exercise program (HEP) including endurance exercises, strengthening, and stretching exercises to be completed on days they do not have PT. If the participants return home, they will be asked to complete the HEP at least 3 days per week. The physical therapist will contact the participant weekly to modify the HEP if necessary and determine compliance.; Other Names: Physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of a 10 week physical therapy intervention program	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.	Up to 12 weeks post surgery

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: Tennessee Physical Therapy Association
• Investigators: Principal Investigator: Angela M. Corr, PT, DPT, St. Jude Children'S Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (ESTIMATE): August 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Lower extremity malignancy
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Neoplasms, Fibrous Tissue; Neoplasms; Sarcoma; Sarcoma, Ewing; Osteosarcoma; Rhabdomyosarcoma; Chondrosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Histiocytoma; Histiocytoma, Benign Fibrous
• Other Study ID Numbers: PTSARC; TPTA (YR 1) (OTHER: Tennessee Physical Therapy Association); NCI-2012-01920 (REGISTRY: NCI Clinical Trial Registration Program)