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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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-09-30

Brief Summary

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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

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This is a two-group randomized controlled trial (RCT) 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).

Conditions

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Exercise Lung Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Group Type EXPERIMENTAL

LTGO-Home Based Exercise

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Annette DeVito Dabbs, PhD, RN

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 36644217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34282853 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33887443 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/36644217/

Exercise Progression Protocol for LTGO

Other Identifiers

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1R01NR017196-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19020357

Identifier Type: -

Identifier Source: org_study_id

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