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
- Are there results?
- Not yet: the study is under way
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
Show all 9Show fewer
- 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
Show all 11Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety
- ClinicalTrials.gov ID
- NCT06960421
- Acronym / sponsor ID
- XFIT / 25-43803
- Conditions
- Frailty, Lung Tranplant Candidate
- Keywords
- frailty, lung transplant, prehabilitation, remote intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of North Carolina, Columbia University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- We will randomize 1:1 into XFIT intervention versus enhanced standard of care using sex and frailty severity as stratification variables
| Arm | Type | Receives |
|---|---|---|
| XFIT | Active comparator | Behavioral: XFITXFIT 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 | 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - 65 years
- Lung Transplant Candidates
- Speaks English or Spanish
- ≤ 8LPM O2 on 6MWT
- SPPB score ≤ 10
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XFITXFIT 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. | Behavioural | XFIT |
Primary outcome
Death
Time frame: 8 weeks
Major cardiovascular event
Time frame: 8 weeks
> 2 unplanned hospitalizations
Time frame: 8 weeks
3 secondary outcomes
Desaturation
Time frame: 8 weeks
Coughing
Time frame: 8 weeks
Presyncope
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- NIH Reporter study descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Singer, MD, MS principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Legna Betancourt (415-476-8073, legna.betancourt@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.