Get Fit for Function

NCT06359652 | Recruiting FDA Device

• 1 other identifier: IRB24-0421
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic; Frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (1)

Prehabilitation Program Participant

OTHER

Device: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook)

Interventions

Prehabilitation Program (Apple Watch Series 6 with exercise flipbook) DEVICE

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.

Prehabilitation Program Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent
• Unable to read/speak English
• Age \<17

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Madariaga, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Madariaga, MD

CONTACT

773-702-2500; mlmadariaga@bsd.uchicago.edu

Viviana Camacho

CONTACT

773-795-4391; vcamacho@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 11, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (1)