An eXercise-based Frailty Intervention in Lung Transplantation (XFIT): A Phase Ib Clinical Trial Focused on Establishing Safety
University of California, San Francisco
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
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 feasibil…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 pulmona…
Interventions
- BehavioralXFIT
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.
Locations (4)
- University of California,San FranciscoSan Francisco, California
- Columbia UniversityNew York, New York
- University of North CarolinaChapel Hill, North Carolina
- University of PennsylvaniaPhiladelphia, Pennsylvania