Physical Therapy for Limb structure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Arizona, Scottsdale, AZ
Limb structure+7 More
Physical Therapy - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Limb structure
  • Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Study Objectives

6 Primary · 2 Secondary · Reporting Duration: At 2, 6, and 12 weeks

Week 12
Functional walking capacity
Toronto Extremity Salvage Score
Up to 22 weeks
Daily step count
Efficacy potential
Feasibility as measured by recruitment, retention, adherence, and acceptability
Gait quality
Global health related quality of life
Symptom status

Trial Safety

Trial Design

2 Treatment Groups

Arm II (educational materials)
1 of 2
Arm I (prehabilitation physical therapy)
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Physical Therapy · No Placebo Group · N/A

Arm I (prehabilitation physical therapy)Experimental Group · 6 Interventions: Physical Therapy, Computed Tomography, Educational Intervention, Magnetic Resonance Imaging, Questionnaire Administration, Telemedicine · Intervention Types: Procedure, Procedure, Other, Procedure, Other, Other
Arm II (educational materials)ActiveComparator Group · 5 Interventions: Computed Tomography, Educational Intervention, Magnetic Resonance Imaging, Questionnaire Administration, Telemedicine · Intervention Types: Procedure, Other, Procedure, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical Therapy
2020
Completed Phase 4
~1330
Computed Tomography
2017
Completed Phase 2
~3460
Magnetic Resonance Imaging
2017
Completed Phase 2
~1120

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 2, 6, and 12 weeks
Closest Location: Mayo Clinic in Arizona · Scottsdale, AZ
Photo of Scottsdale 1Photo of Scottsdale 2Photo of Scottsdale 3
2011First Recorded Clinical Trial
0 TrialsResearching Limb structure
225 CompletedClinical Trials

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,686,131 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,430 Total Patients Enrolled
Krista A GouldingPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity.
You are able to provide appropriate consent or have an appropriate representative available to do so.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.