Get Fit for Function

Early Phase 1

Recruiting

• Conditions: Frailty; Thoracic
• Interventions: Device: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook)

• Registration Number: NCT06359652
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study Start: 2024-04-11
• Study First Posted: 2024-04-11
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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
• Age <17

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation Program Participant	Prehabilitation Program (Apple Watch Series 6 with exercise flipbook)	-

Primary Outcome Measures

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

Name	Time	Method
Number of Participants with Postoperative Complications	From Visit 2 at the time of operation until post-operative Follow-up Visit up to 6 months.
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.

Trial Locations

Locations (1)

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