CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
LTGO-Home Based Exercise +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03728257
NCT03728257N/ACompleted

Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation

University of Pittsburgh·interventional·Posted Nov 2, 2018·Updated Oct 21, 2024

In Brief

A clinical study evaluating LTGO-Home Based Exercise and Enhanced Usual Care for Exercise and Lung Transplantation. Completed, enrolled 88 participants across 1 site.

Detailed Summary

Estimated costs, from thirty days prior to lung transplant up through six months post surgery, exceed 1 million dollars per patient and routine medical costs average approximately fifty thousand dollars per year thereafter. Prior to transplant, lung transplant recipients self restrict activity due to severe respiratory limitations, resulting in reduced muscle mass and qualitative changes in large skeletal muscles. After transplant, despite improved lung function, studies consistently report that lung recipients fail to reach predicted physical function and physical activity. Nearly seventy percent are at risk of developing hypertension within the first five years due to side effects of immunosuppression and an inactive lifestyle worsens this risk. Consequently, full benefits of transplant may not be achieved. Few studies have tested ways to engage lung recipients in self management of exercise and adopt an active lifestyle. Lung Transplant Go LTGO is a behavioral exercise intervention that provides individualized exercise training integrated with behavioral coaching delivered in the recipient's home. Exercise training will focus on assisting lung recipients to learn and practice exercises to reverse muscle conditioning. Behavioral coaching will assist them to develop the skills to self manage physical activity in daily life and maintain this as a sustained habit using strategies that include incremental goal setting, self-monitoring, feedback and problem solving.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 2, 2018
Enrollment StartApr 1, 2019
Primary CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.7 years ago

Interventions

LTGO-Home Based Exercisebehavioral

The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, Versatile and Integrated System for Tele-Rehabilitation (VISYTER)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement

Enhanced Usual Carebehavioral

Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.