Intervention for Pre-Frailty and Frailty in Thoracic Surgery Patients

Not Applicable

Completed

• Conditions: Frailty
• Interventions: Other: Physical Therapy

• Registration Number: NCT02522533
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07-20
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-10
• Study First Posted: 2015-08-13
• Primary Completion: 2017-10-16
• Study Completion: 2017-10-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physical Therapy	Physical Therapy	Patients will be receiving 6 weeks of an exercise program.

Primary Outcome Measures

Name	Time	Method
Reduction in the degree of frailty after strength training	18 months

Secondary Outcome Measures

Name	Time	Method
Changes in surgeon risk assessment after strength training	18 months

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States