Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Frailty has been associated with poor acute and long-term outcomes after major surgery. We recently determined that nearly 70% of patients undergoing major thoracic surgery are pre-frail or frail. We are interested in assessing whether a strength training intervention for frail or pre-frail patients has an impact on surgical decision making and on surgical outcomes.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: • Age ≥60 years, • Qualified to consent for participation in a research study, •Thoracic disease that may require major surgery (major anatomic lung resection, esophagectomy, repair of giant paraesophageal hernia, chest wall resection, extended pleurectomy/decortication, thymectomy or major surgery for other mediastinal process),• No obvious contraindications to surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would prevent surgery), • Ability to participate in physical therapy and an independent exercise program for frailty mitigation, •No need for induction chemotherapy or radiation therapy, • Recent evaluation including computed tomography of the chest or chest/abdomen.

Exclusion Criteria:• Age <60 years, •Unable to provide informed consent, • No indication for major thoracic surgery, •Obvious contraindication to major thoracic surgery (end-stage heart disease, end-stage lung disease, severe dementia, other specific comorbidity that would preclude surgery),• Inability to participate in physical therapy and/or an independent home exercise for frailty mitigation, •Need for induction chemotherapy or radiation therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Therapy; Patients will be receiving 6 weeks of an exercise program.	Other: Physical Therapy; 6 weeks of an exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in the degree of frailty after strength training	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in surgeon risk assessment after strength training	18 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Mark Ferguson, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2015
• Primary Completion (Actual): October 16, 2017
• Study Completion (Actual): October 16, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: IRB15-0192