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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a two-group randomized controlled trial comparing LTGO to enhanced usual care (EUC). Based on estimations using a published RCT, effect sizes measured by Cohen's d ranged from 0.64 to 1.45 across outcome variables (i.e., 0.64 for physical function; 0.73-0.99 for physical activity; and 1.19 and1.45 for systolic and diastolic BP with 80% power, α=0.05). With a final sample of 80 subjects (40 per group) we will have 80% power to detect an effect size as small as 0.64 (α=0.05, two-tailed) from independent sample t-test for measures of physical function, physical activity and hypertension onset/control. Recruiting and randomizing 112 individuals (56 in LTGO & 56 in EUC) will allow for up to 30% attrition. Participants will be randomized to LTGO or EUC (1:1). The biostatistician will randomize participants using a blocked randomization scheme, stratified by sex (male vs. female) and length of hospital stay (≤2 wks vs.>2 wks). The block size (2 or 4) will be randomly selected to prevent prediction of group assignment. An intention-to-treat (ITT) approach will be used. All subjects will be analyzed in the group to which they were randomly assigned, regardless of adherence to the protocol, treatment received, and/or withdrawal from the protocol. Endorsed by international regulatory guidelines, the ITT approach is widely used in RCT because it minimizes the potential for the introduction of biases into data analysis and maintains prognostic balance generated from original random treatment allocation. Although the ITT approach is recommended for efficacy analysis in RCTs, the sensitivity of the results assumes that ITT will be explored using information collected regarding fidelity and dosage (e.g., number of sessions completed).

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

Conditions
-----------------
Exercise, Lung Transplantation

Intervention / Treatment
-----------------
* Behavioral: LTGO-Home Based Exercise
* Behavioral: Enhanced Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older ->4 weeks after the participant had lung transplant surgery Discharged from the hospital after your lung transplant surgery MD report of difficulty walking ¼ mile or climbing 10 steps without resting Medical monitor approves patient eligibility for participation Exclusion Criteria: concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period with no plans to stop formal exercise having other chronic conditions that may severely limit participation in exercise training, i.e., cardiac, musculoskeletal or cognitive impairments does not have home internet or smart device with Bluetooth capabilities medical issue precluding participation declining to be asked screening questions, or declining an introduction to the research team to hear about research greater than 18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two groups. The research study that will compare two methods of self-managing exercise after receiving a lung transplant. These methods are a home-based exercise program plus self-monitoring or self-monitoring alone. The investigator would also like to collect information about the patients health and ability to exercise, and the amount of physical activity the participants do per day. The length of the study will be 6 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LTGO-Home Based Exercise<br>The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. | Behavioral: LTGO-Home Based Exercise<br>* The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/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<br>|
| Active Comparator: Enhanced Usual Care<br>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. | Behavioral: Enhanced Usual Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function-Walking, Change is being Assessed from baseline to 3 months | Walking ability using a 6 minute walk test. The 6MWT is a standardized, well-validated measure of functional capacity. Testing will be conducted according to American Thoracic Society (ATS) Guidelines. *alternate measures added due to COVID: 30 Second Chair Stand Test and Avg Steps per day over 5 days | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical function- Walking-Change is being Assessed from baseline to 6months | Walking ability using a 6 minute walk test. The 6MWT is a standardized, well-validated measure of functional capacity. Testing will be conducted according to American Thoracic Society (ATS) Guidelines. *alternate measures added due to COVID: 30 Second Chair Stand Test and Avg Steps per day over 5 days | The change will be measured from baseline to 6 months, post-randomization. | 
| Physical function- Balance-Change is being Assessed from baseline to 3 months | Using the Berg Balance Scale for lower body strength. Berg Balance Scale (14 items) will measure balance.[31, 32] This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Total score ranges from 0 to 56 (higher score = better balance). | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical function- Balance-Change is being Assessed from baseline to 6 months | Using the Berg Balance Scale for lower body strength. Berg Balance Scale (14 items) will measure balance.[31, 32] This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Total score ranges from 0 to 56 (higher score = better balance). | The change will be measured from baseline to 6 months, post-randomization. | 
| Physical function- Lower Body Strength-Change is being Assessed from baseline to 3 months. | Using the 30 Second Chair Stand Test. 30-second Chair-Stand test will measure lower body strength. The LTR participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, LTR will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. More repetitions indicate better lower body strength. | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical function- Lower Body Strength-Change is being Assessed from baseline to 6 months. | Using the 30 Second Chair Stand Test. 30-second Chair-Stand test will measure lower body strength. The LTR participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On Go, LTR will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. More repetitions indicate better lower body strength. | The change will be measured at baseline to 6 months, post-randomization. | 
| Physical function- Maximal exercise watts per Kg of bodyweight change is being assess from baseline to 3 months. | The maximal exercise watts per kg of bodyweight defined as the actual energy being created by an exercise motion during the cardiopulmonary exercise test. | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical function- respiratory related quality of life is being assess from baseline to 3 months. | Using the St. George Respiratory Questionnaire | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical function- respiratory related quality of life is being assess from baseline to 6 months. | Using the St. George Respiratory Questionnaire | The change will be measured from baseline to 6 months, post-randomization. | 
| Physical Activity-Change is being Assessed from baseline to 3 months. | Using the Actigraph GT3X. It is an accelerometer monitor which will measure physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph on their waist for 7 days (starting the following day) during waking hours (≥10 hours of wear/day) except during imaging studies, bathing or shower. *alternate measure International Physical Activity Questionnaire-S added due to COVID. | The change will be measured from baseline to 3 months, post-randomization. | 
| Physical Activity-Change is being Assessed from baseline to 6 months. | Using the Actigraph GT3X. It is an accelerometer monitor which will measure physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph on their waist for 7 days (starting the following day) during waking hours (≥10 hours of wear/day) except during imaging studies, bathing or shower. *alternate measure International Physical Activity Questionnaire-S added due to COVID. | The change will be measured from baseline to 6 months, post-randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control-Change Assessed, from baseline to 3 months | Using a blood pressure monitoring device to measure blood pressure control, thus preventing onset of hypertension or controlling existing hypertension. | The change will be measured from baseline to 3 months, post-randomization. | 
| Blood Pressure Control-Change Assessed, from baseline to 6 months | Using a blood pressure monitoring device to measure blood pressure control, thus preventing onset of hypertension or controlling existing hypertension. | The change will be measured from baseline to 6 months, post-randomization. |