Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359652
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-04-08
Brief Title:
Get Fit for Function
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Get Fit for Function Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None