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ClinicalTrials.gov ID

NCT06960421

Lead Sponsor

University of California, San FranciscoOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

70Estimated

Last Update Posted

Jun 3, 2025Actual

Start Date

Jul 15, 2026Estimated

Primary Completion Date

Jul 1, 2029Estimated

Completion Date

Jul 1, 2029Estimated

Official Title

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

Brief 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. 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.

• Frailty
• Lung Tranplant Candidate

• XFIT

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

University of California, San FranciscoOTHER

Collaborators

University of PennsylvaniaOTHER

University of North CarolinaOTHER

Columbia UniversityOTHER

National Heart, Lung, and Blood Institute (NHLBI)NIH

sp3646@cumc.columbia.edu973-722-6835