Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

NCT ID: NCT06960421

Last Updated: 2025-06-03

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-07-15

Study Completion Date

2029-07-01

Brief Summary

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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

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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.

Conditions

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Frailty Lung Tranplant Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

XFIT

Intervention Type 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.

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 - 65 years
* 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

* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Columbia University

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Legna Betancourt

Role: CONTACT

415-476-8073

Facility Contacts

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Legna Betancourt

Role: primary

415-476-8073

Shreena Patel

Role: primary

973-722-6835

Patrick Smith, PhD

Role: primary

919-966-9812

Michaela Anderson, MD

Role: primary

215-615-5864

Related Links

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Other Identifiers

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1R61HL169183

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-43803

Identifier Type: -

Identifier Source: org_study_id

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