Exercise-based Frailty Intervention in Lung Transplantation (XFIT)

University of California San Francisco (UCSF)

Status: Begins enrollment in a year or more

Conditions: Frailty; Lung Tranplant Candidate

Treatments: Behavioral: XFIT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06960421

1R61HL169183 (U.S. NIH Grant/Contract)

25-43803

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

XFIT

Active Comparator group

Description:

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.

Treatment:

Behavioral: XFIT

Enhanced standard of care

No Intervention group

Description:

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.