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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960421
Acronym
XFIT
Enrollment
70
Registered
2025-05-07
Start date
2026-07-15
Completion date
2029-07-01
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Lung Tranplant Candidate

Keywords

frailty, lung transplant, prehabilitation, remote intervention

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.

Interventions

BEHAVIORALXFIT

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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
University of North Carolina
CollaboratorOTHER
Columbia University
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

We will randomize 1:1 into XFIT intervention versus enhanced standard of care using sex and frailty severity as stratification variables

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Death8 weeks
Major cardiovascular event8 weeks
> 2 unplanned hospitalizations8 weeks

Secondary

MeasureTime frame
Desaturation8 weeks
Coughing8 weeks
Presyncope8 weeks

Countries

United States

Contacts

Primary ContactLegna Betancourt
legna.betancourt@ucsf.edu415-476-8073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026