Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

Official title

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

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Death [Time frame: 8 weeks]
• Major cardiovascular event [Time frame: 8 weeks]
• > 2 unplanned hospitalizations [Time frame: 8 weeks]

Secondary outcome measures (3)

• Desaturation [Time frame: 8 weeks]
• Coughing [Time frame: 8 weeks]
• Presyncope [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

United States · 4 centers

• University of California,San Francisco — San Francisco
• Columbia University — New York
• University of North Carolina — Chapel Hill
• University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06960421 · 25-43803 · 1R61HL169183

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗