Clinical trial · Interventional
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
NCT01674101CI-TRIAL-00020065completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chondrosarcoma of the Bone | — | UNRESOLVED | — |
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
| Malignant Fibrous Histiocytoma of the Bone | Undifferentiated High Grade Pleomorphic Sarcoma of Bone | ALIAS | 0.90 |
| Malignant Peripheral Nerve Sheath Sarcoma | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Synovial Sarcoma | Synovial Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endurance | Other | — | UNRESOLVED |
| Home exercise program | Other | — | UNRESOLVED |
| Strengthening | Other | — | UNRESOLVED |
| Stretching | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Physical Therapy
- 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.
- interventionNames
- Other: Endurance
- Other: Strengthening
- Other: Stretching
- Other: Home exercise program
Primary outcomes (1)
- measure
- Feasibility of a 10 week physical therapy intervention program
- timeFrame
- Up to 12 weeks post surgery
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.