Recruiting

Prehabilitation

Sponsor:

Mayo Clinic

Code:

NCT05526417

Conditions

Soft Tissue Sarcoma

Stage I Soft Tissue Sarcoma of the Trunk and Extremities

Stage II Soft Tissue Sarcoma of the Trunk and Extremities

Stage III Soft Tissue Sarcoma of the Trunk and Extremities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Educational Intervention

Magnetic Resonance Imaging

Physical Therapy

Questionnaire Administration

Study Details

Brief 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.

Conditions

Soft Tissue Sarcoma

Stage I Soft Tissue Sarcoma of the Trunk and Extremities

Stage II Soft Tissue Sarcoma of the Trunk and Extremities

Stage III Soft Tissue Sarcoma of the Trunk and Extremities

Study ID

NCT05526417

Start date

Jun 8, 2022

Status verified date

Jun, 2026

Completion date

Jun 8, 2028

Anticipated

Primary completion date

Jun 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (prehabilitation physical therapy)

Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.

active comparator: Arm II (educational materials)

Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.

Interventions

Computed Tomography

Undergo CT

Educational Intervention

Receive educational materials

Magnetic Resonance Imaging

Undergo MRI

Physical Therapy

Receive prehabilitation physical therapy

Questionnaire Administration

Ancillary studies

Telemedicine

Attend telemedicine visits

Primary outcome measure

  • Feasibility as measured by recruitment, retention, adherence, and acceptability [ Time Frame: Up to 22 weeks ]
  • Efficacy potential [ Time Frame: Up to 22 weeks ]
  • Toronto Extremity Salvage Score [ Time Frame: At 2, 6, and 12 weeks ]
  • Functional walking capacity [ Time Frame: At 2, 6, and 12 weeks ]
  • Gait quality [ Time Frame: Up to 22 weeks ]
  • Daily step count [ Time Frame: Up to 22 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Clinical Trial Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Krista A. Goulding, MD, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-22.