FrailtyXFITNCT06960421
Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
A study testing XFIT in people with Frailty and Lung Tranplant Candidate, run by University of California, San Francisco at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frailty, Lung Tranplant Candidate
- What is being tested?
- XFIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Oct 2026to 1 Jul 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years
- Lung Transplant Candidates
- Speaks English or Spanish
- ≤ 8LPM O2 on 6MWT
- SPPB score ≤ 10
- Age 18 - 75 years
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- Speaks English or Spanish
- ≤ 15LPM O2 on 6MWT
- SPPB score ≤ 10
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
Patrick Smith, PhD, 919-966-9812, Patrick_Smith@med.unc.edu
Patrick Smith, PhD
- Not yet recruiting
Columbia University
New York, New York, 10032
Shreena Patel, 973-722-6835, sp3646@cumc.columbia.edu
Luke Benvenuto, MD
- Not yet recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Michaela Anderson, MD, 215-615-5864, michaela.anderson@pennmedicine.upenn.edu
Michaela Anderson, MD
- Recruiting
University of California,San Francisco
San Francisco, California, 94143
Legna Betancourt, 415-476-8073, legna.betancourt@ucsf.edu
Jonathan Singer, MD, MS
About this study
Official title: An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety
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
Read the detailed description
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
- Frailty, Lung Tranplant Candidate
- Being tested
- XFIT
- Keywords
- frailty, lung transplant, prehabilitation, remote intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XFITBehavioural
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 group | Role | What they receive |
|---|---|---|
| XFIT | Active comparator | 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. Receives: Behavioral: XFIT |
| Enhanced standard of care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 8 weeks
Major cardiovascular event
Measured: 8 weeks
> 2 unplanned hospitalizations
Measured: 8 weeks
Secondary outcomes (3)
Desaturation
Measured: 8 weeks
Coughing
Measured: 8 weeks
Presyncope
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start22 Oct 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize 1:1 into XFIT intervention versus enhanced standard of care using sex and frailty severity as stratification variables
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of North Carolina, Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Singer, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960421
- Sponsor's protocol ID
- 25-43803
- Other IDs
- 1R61HL169183
- Acronym
- XFIT
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymized dataset with key study-related data will be made available to investigators upon request one-year after the publication of the primary study findings. Investigators will be able to make requests through Drs. Singer and Smith, who can facilitate such data management tasks. In addition, we will plan to provide a complete, anonymized dataset for deposition into online data repositories within three years of publication of our primary findings, for use in subsequent follow-up analyses or meta-analytic studies. We will also make annotated statistical analytical code available for public usage, in order to increase reproducibility of findings for future studies. We will also make available our final protocol. These data will be available in an online data repository for as long as the repository is able to host them. They will also be available for request from Drs. Singer and Smith.