Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | March 25, 2019 |
| End Date: | April 8, 2022 |
| Contact: | Annette DeVito Dabbs, PhD |
| Email: | ajdst42@pitt.edu |
| Phone: | 4126245314 |
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.
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.
This is a two-group randomized controlled trial comparing LTGO to enhanced usual care (EUC).
Participants will be 112 LTR 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).
Participants will be 112 LTR 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).
Inclusion Criteria:
- 18 years of age or older
- Approved by your transplant physician to participate in this research study
- Discharged from the hospital after your lung transplant
- 4 weeks after the participant had lung transplant surgery
- Experiencing difficulty walking a short distance or climbing steps without resting
Exclusion Criteria:
- concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation,
during the study period (Rationale: to ensure internal validity)
- current residence located > 120 miles from data collection site (Rationale: setting up
the VISYTER system requires a home visit)
- having other chronic conditions that may limit participation in exercise training,
i.e., cardiac, musculoskeletal or cognitive impairments (Rationale: lung transplant
recipients may have other comorbid conditions).
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