Menu
Recruiting NCT06359652

Get Fit for Function

No phase Interventional Thoracic Frailty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook).
Who it may be relevant to
Registry conditions: Thoracic, Frailty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Get Fit for Function Pilot Study

Overview

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

  • 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.

Primary outcome measures

  • The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation. [Time frame: 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 outcome measures (3)
  • Number of Participants with Postoperative Complications [Time frame: 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. [Time frame: From Visit 2 at the time of operation until day of discharge.]
  • Number of Participants discharge to not-home post-operative. [Time frame: From Visit 2 at the time of operation until Visit 3 for post operative clinic visit.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • The University of Chicago — Chicago

Identifiers

NCT: NCT06359652 · IRB24-0421

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗