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NCT Number: NCT06960421

Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California,San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Death

    Time frame: 8 weeks

  2. Major cardiovascular event

    Time frame: 8 weeks

  3. > 2 unplanned hospitalizations

    Time frame: 8 weeks

Secondary outcomes

  1. Desaturation

    Time frame: 8 weeks

  2. Coughing

    Time frame: 8 weeks

  3. Presyncope

    Time frame: 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Legna Betancourt

CONTACT

[email protected]

415-476-8073

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Columbia University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of North Carolina
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: XFIT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 7, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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