Exercise-based Frailty Intervention in Lung Transplantation (XFIT)
- Conditions
- FrailtyLung Tranplant Candidate
- Registration Number
- NCT06960421
- Lead Sponsor
- University of California, San Francisco
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Age 18 - 65 years
- Lung Transplant Candidates
- Speaks English or Spanish
- ≤ 8LPM O2 on 6MWT
- SPPB score ≤ 10
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Death 8 weeks Major cardiovascular event 8 weeks > 2 unplanned hospitalizations 8 weeks
- Secondary Outcome Measures
Name Time Method Desaturation 8 weeks Coughing 8 weeks Presyncope 8 weeks
Trial Locations
- Locations (4)
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