Clinical trial NCT01674101: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Tennessee Physical Therapy Association
First posted: 2012-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility of a 10 week physical therapy intervention program
timeFrame: Up to 12 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Angela M. Corr, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: