Recruiting

XFITExercise-based Frailty Intervention in Lung Transplantation (XFIT)

Sponsor:

UCLA

Code:

NCT06960421

Conditions

Frailty

Lung Tranplant Candidate

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

XFIT

Study Details

Brief 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

Conditions

Frailty

Lung Tranplant Candidate

Study ID

NCT06960421

Start date

Oct 22, 2026

Status verified date

Oct, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Group 1

Inclusion Criteria:

Age 18 - 65 years
Lung Transplant Candidates
Speaks English or Spanish
≤ 8LPM O2 on 6MWT
SPPB score ≤ 10

Exclusion Criteria:

Lives Alone
BMI < 18.0 kg/m2
Engaged in clinical pulmonary rehabilitation program
Severe pHTN (RHC mPAP ≥ 30 mmHg or TTE PASP ≥ 60mmHg or moderately/severely reduced RV systolic function on TTE
Deemed unsafe by site PI

Group 2

Inclusion Criteria:

Age 18 - 75 years
Speaks English or Spanish
≤ 15LPM O2 on 6MWT
SPPB score ≤ 10

Exclusion Criteria:

Lives Alone
BMI < 18.0 kg/m2
Engaged in clinical pulmonary rehabilitation program
Severely reduced RV systolic function on TTE
Deemed unsafe by site PI

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: 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.

no intervention: Enhanced standard of care

Participants in ESC will be provided with individualized recommendations to improve physical frailty tailored to their baseline assessments, as well as contemporary information on treatments for physical frailty published by the NIH's Science of Frailty group (https://frailtyscience.org/). ESC participants will not engage in weekly treatment sessions, wear activity trackers throughout the intervention period, or receive the personalized psychological treatment provided to those in XFIT.

Interventions

XFIT

Primary outcome measure

Death [ Time Frame: 8 weeks ]
Major cardiovascular event [ Time Frame: 8 weeks ]
> 2 unplanned hospitalizations [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Legna Betancourt

415-476-8073 legna.betancourt@ucsf.edu

Locations

University of California,San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Legna Betancourt

415-476-8073 legna.betancourt@ucsf.edu

Principal Investigator:

Jonathan Singer, MD, MS

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

frailty
lung transplant
prehabilitation
remote intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.