PTSARC: Physical Therapy in Young Patients With Lower Extremity Malignancies Before Surgery

Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed with a Lower Extremity Malignancy

Categories:

Long-term Effects

Supportive Solid Tumor Studies

Diseases Treated:

Solid tumors

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

  • Please see clinical trial for full inclusion and exclusion eligibility criteria.

Description

This study evaluates the feasibility and the effect of adding a focused physical therapy intervention to the preoperative regimen in individuals diagnosed with a malignancy of the lower extremity. The intervention group will receive preoperative physical therapy at least 3 times per week for 60 minutes each session to the uninvolved leg. The therapy sessions will include endurance, strengthening, and stretching exercises. The results measures for this study are the Functional Mobility Assessment (FMA), strength and range of motion (ROM) of bilateral lower extremities (BLE’s). PT to be conducted for 10 weeks prior to the limb sparing procedure or amputation and for 10-12 weeks after the limb sparing procedure or amputation.

Objectives

Primary

  • To determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

Exploratory

  • To evaluate the impact of preoperative strengthening and aerobic exercise training on function at 10-12 weeks postoperatively in children diagnosed with a malignancy of the LE who will be receiving a limb sparing procedure or amputation.

Eligibility

Inclusion Criteria

  • Participant must be between the ages of 6 and 30 years of age.
  • Participant must be granted permission by physician.
  • Participant has negative pregnancy test.
  • Lansky score > 50 for participants age < 16 years of age.
  • Karnofsky score of > 50 or WHO/ECOG < 2 if > 16 years of age.
  • Participant has a newly diagnosed lower extremity malignancy as shown by biopsy; previously untreated and surgical intervention is primary local control and is being treated at St. Jude Children’s Research Hospital.

Exclusion Criteria

  • Participants with serious, non-healing wound, ulcer or bone fracture.
  • Participant has a pre-morbid condition that prevents participant from ambulating.
  • Patients who do not have at least 10 weeks before receiving local control.

Principal Investigator

Angela Meyer Corr, PT, DPT

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.