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Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

Primary Purpose

Osteosarcoma, Ewing's Sarcoma, Rhabdomyosarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endurance
Strengthening
Stretching
Home exercise program
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteosarcoma focused on measuring Lower extremity malignancy

Eligibility Criteria

6 Years - 30 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Therapy

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2012
Last Updated
December 3, 2015
Sponsor
St. Jude Children's Research Hospital
Collaborators
Tennessee Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT01674101
Brief Title
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy
Official Title
A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
Tennessee Physical Therapy Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma, Ewing's Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma, Malignant Peripheral Nerve Sheath Sarcoma, Malignant Fibrous Histiocytoma of the Bone, Chondrosarcoma of the Bone
Keywords
Lower extremity malignancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Endurance
Other Intervention Name(s)
Physical therapy
Intervention Description
Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.
Intervention Type
Other
Intervention Name(s)
Strengthening
Other Intervention Name(s)
Physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching
Other Intervention Name(s)
Physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home exercise program
Other Intervention Name(s)
Physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of a 10 week physical therapy intervention program
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.
Time Frame
Up to 12 weeks post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M. Corr, PT, DPT
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

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Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

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