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| ID | Type | Description | Link |
|---|---|---|---|
| TPTA (YR 1) | Other Identifier | Tennessee Physical Therapy Association | |
| NCI-2012-01920 | Registry Identifier | NCI Clinical Trial Registration Program |
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| Name | Class |
|---|---|
| Tennessee Physical Therapy Association | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance | Other | Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela M. Corr, PT, DPT | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| Strengthening | Other | 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. |
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| Stretching | Other | 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. |
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| Home exercise program | Other | 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. |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D013584 | Sarcoma, Synovial |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D005081 | Exercise Therapy |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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