Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06960421
Status
Not Yet Recruiting

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Conditions

  • Frailty
  • Lung Tranplant Candidate

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

Start date
Jul 15, 2026
Status verified
May 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

Death [ Time Frame: 8 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California,San FranciscoSan FranciscoCalifornia94143
Legna Betancourt
[email protected]
415-476-8073
Jonathan Singer, MD, MS (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Shreena Patel
[email protected]
973-722-6835
Luke Benvenuto, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27599
Patrick Smith, PhD
[email protected]
919-966-9812
Patrick Smith, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Michaela Anderson, MD
[email protected]
215-615-5864
Michaela Anderson, MD (PRINCIPAL_INVESTIGATOR)

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