Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674101
• Other study ID #: PTSARC
• Secondary ID: TPTA (YR 1)NCI-2
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: December 3, 2015
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 30 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chondrosarcoma
• Chondrosarcoma of the Bone
• Ewing's Sarcoma
• Histiocytoma
• Histiocytoma, Malignant Fibrous
• Malignant Fibrous Histiocytoma of the Bone
• Malignant Peripheral Nerve Sheath Sarcoma
• Osteosarcoma
• Rhabdomyosarcoma
• Sarcoma
• Sarcoma, Ewing
• Sarcoma, Synovial
• Synovial Sarcoma

Intervention

Other:
• Endurance
Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Tennessee Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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