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Get Fit for Function

Get Fit for Function Pilot Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06359652
Enrollment
100
Registered
2024-04-11
Start date
2024-04-11
Completion date
2029-04-30
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Thoracic

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.

Interventions

DEVICEPrehabilitation 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.

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Number of Participants with Postoperative ComplicationsFrom 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.

Countries

United States

Contacts

Primary ContactMaria Madariaga, MD
mlmadariaga@bsd.uchicago.edu773-702-2500
Backup ContactViviana Camacho
vcamacho@bsd.uchicago.edu773-795-4391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026