Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
NCT ID: NCT03728257
Last Updated: 2024-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2019-04-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LTGO-Home Based Exercise
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.
LTGO-Home Based Exercise
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 Care
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.
Enhanced Usual Care
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.
Interventions
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LTGO-Home Based Exercise
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 Care
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.
Eligibility Criteria
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Inclusion Criteria
-\>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
* 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.)
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Annette DeVito Dabbs, PhD, RN
Professor and Chairman
Principal Investigators
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Annette DeVito Dabbs, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh, School of Nursing
Pittsburgh, Pennsylvania, United States
Countries
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References
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Hergenroeder AL, Willey B, Vendetti M, Dabbs AD. Exercise Progression Protocol for Lung Transplant GO: A Multicomponent Telerehab Exercise Intervention for Patients After Lung Transplantation. Cardiopulm Phys Ther J. 2023 Jan;34(1):2-12. doi: 10.1097/CPT.0000000000000203. Epub 2022 Mar 23. No abstract available.
Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Moon SJE, Dabbs AD, Hergenroeder AL, Vendetti ML, Jones KB, Willey BM, Morrell MR, Imes CC. Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic. Contemp Clin Trials. 2021 Jun;105:106407. doi: 10.1016/j.cct.2021.106407. Epub 2021 Apr 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Exercise Progression Protocol for LTGO
Other Identifiers
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STUDY19020357
Identifier Type: -
Identifier Source: org_study_id
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