Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

NCT06960421 — Not applicable, Recruiting, 70 participants, University of California, San Francisco

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

Registry	NCT06960421, acronym XFIT
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, other
Enrollment	70 (Estimated)
Sponsor	University of California, San Francisco (Other); collaborators: University of Pennsylvania, University of North Carolina, Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Frailty, Lung Tranplant Candidate
Interventions	XFIT (Behavioral)
Dates	start 2026-10-22 (estimated), primary completion 2029-07-01 (estimated), completion 2029-07-01 (estimated), first posted 2025-05-07, last updated 2026-10-16
Locations	4 sites in United States

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
XFIT	Active comparator	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.
Enhanced standard of care	No intervention		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.

XFIT (Behavioral): 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

Desaturation [8 weeks]
Coughing [8 weeks]
Presyncope [8 weeks]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (4)

Facility	City	Country	Status
University of California,San Francisco	San Francisco, California	United States	Recruiting
Columbia University	New York, New York	United States	Not yet recruiting
University of North Carolina	Chapel Hill, North Carolina	United States	Not yet recruiting
University of Pennsylvania	Philadelphia, Pennsylvania	United States	Not yet recruiting

+Investigators

Jonathan Singer, MD, MS, Principal investigator, University of California, San Francisco

+Funding

NIH grants: R61HL169183