Get Fit for Function

Frailty Clinical Trial

Official title:

Get Fit for Function Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06359652
• Other study ID #: IRB24-0421
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 11, 2024
• Est. completion date: April 2029

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Maria Madariaga, MD
• Phone: 773-702-2500
• Email: mlmadariaga[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age = 50, of any racial or ethnic origin

• Screened, during a pre-operative Thoracic Surgery Clinic Visit, as Pre-frail or Frail

• 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 <50

Related Conditions & MeSH terms

• Frailty
• Thoracic

Intervention

Device:
• Prehabilitation Program (Apple Watch Series 6 with exercise flipbook)
We will evaluate whether use of a personal device (the Apple Watch) could help medical professionals assess patients' pre-surgery prehab state. It will also assess whether patients are willing to use a personal device and engage in prehab exercise and whether the device can enhance prehab uptake. The intervention is to also offer patients the Exercise Flipbook, to send them a reminder to exercise and to send them notifications to track their exercise.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Postoperative Complications		From Visit 2 at the time of operation until post-operative Follow-up Visit up to 6 months.
Secondary	Number of Participants length of hospital stay post-operative.		From Visit 2 at the time of operation until day of discharge.
Secondary	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.