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Clinical Trials/NCT06359652
NCT06359652
Recruiting
N/A

Get Fit for Function Pilot Study

University of Chicago1 site in 1 country100 target enrollmentApril 11, 2024
ConditionsThoracicFrailty

Overview

Phase
N/A
Intervention
Not specified
Conditions
Thoracic
Sponsor
University of Chicago
Enrollment
100
Locations
1
Primary Endpoint
The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation.
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program.

Detailed Description

Approximately 70% of thoracic surgery patients are pre-frail or frail, characterized by reduced strength, endurance, and physiologic function. Frailty is associated with poor perioperative outcomes, including increased complications, length of stay, post-discharge institutionalization, healthcare costs, and mortality. As a result, surgical and geriatric clinical societies now recommend including a frailty assessment in older adult pre-operative surgical evaluations. To mitigate the risks associated with frailty, prehabilitation (prehab) has been included as a component of the American College of Surgeons "Strong for Surgery" quality initiative. Evidence-based practices to optimize preoperative health have been shown to improve physical conditioning and return to autonomy, as well as, reduce length of stay, postoperative complications, and healthcare costs. Older patients who need surgery view prehab favorably, particularly if it is home-based, recommended by a medical professional, and free. The primary objective will be to conduct a feasibility evaluation using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The secondary objectives will be to measure functional status and clinical outcomes longitudinally in patients undergoing prehab. Participants will receive the prehab program from 2-12 weeks prior to undergoing elective inpatient thoracic surgery. Participants will complete surveys at 2-3 weeks, 2 months, 3-4 months, and 6 months after surgery.

Registry
clinicaltrials.gov
Start Date
April 11, 2024
End Date
April 1, 2029
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18, of any racial or ethnic origin
  • Will be undergoing elective thoracic surgery lung resection using thoracic approach (thoracotomy, Video-assisted thoracoscopic surgery (VATS), Robotic-Assisted Thoracic Surgery (RATS)
  • Able to complete baseline evaluations at time of enrollment

Exclusion Criteria

  • Unable to give informed consent
  • Unable to read/speak English

Outcomes

Primary Outcomes

The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation.

Time Frame: At Visit 1 two to twelve weeks prior to undergoing elective inpatient thoracic surgery until post-operative Follow-up Visit up to 6 months.

Secondary Outcomes

  • Number of Participants length of hospital stay post-operative.(From Visit 2 at the time of operation until day of discharge.)
  • Number of Participants discharge to not-home post-operative.(From Visit 2 at the time of operation until Visit 3 for post operative clinic visit.)
  • Number of Participants with Postoperative Complications(From Visit 2 at the time of operation until post-operative Follow-up Visit up to 6 months.)

Study Sites (1)

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