Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Jonathan Singer, MD, MS
Headshot of Jonathan Singer
Jonathan Singer

Description

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

Official Title

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

Details

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.

Keywords

Frailty, Lung Tranplant Candidate, lung transplant, prehabilitation, remote intervention, XFIT

Eligibility

For people ages 18-75

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

  • UCSF
    San Francisco California 94143 United States
  • University of North Carolina
    Chapel Hill North Carolina 27599 United States
  • University of Pennsylvania
    Philadelphia Pennsylvania 19104 United States
  • Columbia University
    New York New York 10032 United States

Lead Scientist at UCSF

  • Jonathan Singer, MD, MS
    Dr. Jonathan Singer is a Professor of Medicine in the Division of Pulmonary, Critical Care, Allergy and Sleep Medicine. He specializes in the care of adults with advanced lung disease and lung transplant recipients.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
NIH Reporter study description
ID
NCT06960421
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated