Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
NCT ID: NCT06960421
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2026-07-15
2029-07-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Lung Transplant Candidates
* Speaks English or Spanish
* ≤ 8LPM O2 on 6MWT
* SPPB score ≤ 10
* Age 18 - 75 years
* Speaks English or Spanish
* ≤ 15LPM O2 on 6MWT
* SPPB score ≤ 10
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
University of North Carolina
OTHER
Columbia University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jonathan Singer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California,San Francisco
San Francisco, California, United States
Columbia University
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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NIH Reporter study description
Other Identifiers
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25-43803
Identifier Type: -
Identifier Source: org_study_id
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