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Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborator:
Tennessee Physical Therapy Association
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01674101
First received: August 23, 2012
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Osteosarcoma
Ewing's Sarcoma
Rhabdomyosarcoma
Synovial Sarcoma
Malignant Peripheral Nerve Sheath Sarcoma
Malignant Fibrous Histiocytoma of the Bone
Chondrosarcoma of the Bone
Other: Endurance
Other: Strengthening
Other: Stretching
Other: Home exercise program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Feasibility of a 10 week physical therapy intervention program [ Time Frame: Up to 12 weeks post surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Physical therapy

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.

  Eligibility

Ages Eligible for Study:   6 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674101

Contacts
Contact: Angela M. Corr, PT, DPT 866-278-5833 angela.corr@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Angela M. Corr, PT, DPT    866-278-5833    angela.corr@stjude.org   
Principal Investigator: Angela M. Corr, PT, DPT         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Tennessee Physical Therapy Association
Investigators
Principal Investigator: Angela M. Corr, PT, DPT St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01674101     History of Changes
Other Study ID Numbers: PTSARC, TPTA (YR 1)
Study First Received: August 23, 2012
Last Updated: September 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Lower extremity malignancy

Additional relevant MeSH terms:
Chondrosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Neoplasms
Osteosarcoma
Rhabdomyosarcoma
Sarcoma
Sarcoma, Ewing
Sarcoma, Synovial
Myosarcoma
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on November 25, 2014