Clinical trial NCT06359652: Get Fit for Function
Official title: Get Fit for Function Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Thoracic
Frailty
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation.
timeFrame: 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:
measure: Number of Participants with Postoperative Complications
timeFrame: From Visit 2 at the time of operation until post-operative Follow-up Visit up to 6 months.
measure: Number of Participants length of hospital stay post-operative.
timeFrame: From Visit 2 at the time of operation until day of discharge.
measure: Number of Participants discharge to not-home post-operative.
timeFrame: From Visit 2 at the time of operation until Visit 3 for post operative clinic visit.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Maria Madariaga, MD
role: PRINCIPAL_INVESTIGATOR
References: