Pre-Operative ERAS® (Enhanced Recovery After Surgery): Randomized Feasibility Trial of Implementing Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery
Mayo Clinic
Summary
This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.
Description
PRIMARY OBJECTIVES: I. To determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS). II. To identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT), wearable Heel2Toe sensor technology, and daily step count. III. To estimate recruitment, retent…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity * Localized * Adults, 18 and older * All gender types * Subjects must be able to provide appropriate consent or have an appropriate representative available to do so Exclusion Criteria: * Soft tissue sarcomas that are in a superficial location relative to fascia * Patients with metastatic disease (distant or nodal) * Both and upper and lower extremity involvement
Interventions
- ProcedureComputed Tomography
Undergo CT
- OtherEducational Intervention
Receive educational materials
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePhysical Therapy
Receive prehabilitation physical therapy
- OtherQuestionnaire Administration
Ancillary studies
- OtherTelemedicine
Attend telemedicine visits
Location
- Mayo Clinic in ArizonaScottsdale, Arizona