NCT06960421

Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of XFIT study is to measure the safety of an 8-week telehealth-delivered exercise and behavioral training program to treat frailty in lung transplant candidates in their own home. The main questions XFIT aims to answer are: * Is XFIT safe? * Is XFIT feasible and acceptable by participants? * Is XFIT effective in improving frailty and physical function as reflected in patient-reported outcomes. Participants will: \- Participate in the 8-week XFIT program or enhanced standard of care

Detailed description

We will randomize 70 patients who reflect the diversity and spectrum of illness seen in the general lung transplant candidate population to either XFIT or enhanced standard of care. An interventionalist with expertise in exercise physiology and remote interventions will deliver 8 weekly sessions using video-conference software in participants' homes. These sessions feature one-on-one exercise training and targeting of behavioral barriers to optimizing physical activity using motivational interviewing principles. Establishing safety is our primary outcome. We will secondarily establish feasibility and acceptability, and explore responsiveness six-minute walk distance, frailty, Patient Reported Outcomes . We anticipate that this first-of-its kind study in solid organ transplantation will establish fundamental safety, feasibility, and accessibility data needed inform larger scale interventions.

Conditions

• Frailty
• Lung Tranplant Candidate

Interventions

Type	Name	Description
BEHAVIORAL	XFIT	XFIT is an 8-week telehealth-delivered, home-based exercise/behavior modification intervention. It integrates theoretical frameworks of behavior change to engage frail lung transplant candidates in program of pre-habilitation.

Timeline

• Start date: 2026-07-15
• Primary completion: 2029-07-01
• Completion: 2029-07-01
• First posted: 2025-05-07
• Last updated: 2025-06-03

Locations

4 sites across 1 country: United States