Clinical trial NCT06960421: Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
Official title: An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Frailty
Lung Tranplant Candidate
Keywords: frailty
lung transplant
prehabilitation
remote intervention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of North Carolina
name: Columbia University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-05-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize 1:1 into XFIT intervention versus enhanced standard of care using sex and frailty severity as stratification variables
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: 8 weeks
measure: Major cardiovascular event
timeFrame: 8 weeks
measure: > 2 unplanned hospitalizations
timeFrame: 8 weeks
Secondary outcomes:
measure: Desaturation
timeFrame: 8 weeks
measure: Coughing
timeFrame: 8 weeks
measure: Presyncope
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California,San Francisco
state: California
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of California, San Francisco
name: Jonathan Singer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: