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

NCT03728257 | Completed Results DMC

• 2 other identifiers: STUDY190203571R01NR017196-01A1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise; Lung Transplantation

Outcome Measures

Primary Outcomes (10)

• Physical Function- Walking: Change in Average Steps Per Day at Month 3

  Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score).

  Baseline and 3 months

• Physical Function- Walking: Change in Average Steps Per Day at Month 6

  Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).

  Baseline and 6 months

• Physical Function- Balance: Change in Berg Balance at Month 3

  Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (3 month score minus baseline score).

  Baseline and 3 months.

• Physical Function- Balance: Change From Baseline to 6 Months

  Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).

  Baseline and 6 months

• Physical Function-Lower Body Strength: Change From Baseline to 3 Months

  Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The 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," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score).

  Baseline and 3 months.

• Physical Function-Lower Body Strength: Change From Baseline to 6 Months

  Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The 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," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score).

  Baseline and 6 months.

• Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.

  Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score).

  Baseline and 3 months.

• Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.

  Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score).

  Baseline and 6 months

• Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.

  The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score).

  Baseline and 3 months.

• Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.

  The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (6 month score minus baseline score).

  Baseline and 6 months.

Secondary Outcomes (2)

• Blood Pressure Control-Change From Baseline to 3months

  Baseline and 3 months

• Blood Pressure Control-Change From Baseline to 6 Months

  Baseline and 6 months.

Study Arms (2)

LTGO-Home Based Exercise

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

LTGO-Home Based Exercise 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

LTGO-Home Based Exercise

Enhanced Usual Care 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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh, School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (3)

• 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.

  PMID: 36644217 BACKGROUND

• 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.

  PMID: 34282853 DERIVED

• 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.

  PMID: 33887443 DERIVED

Related Links

• Exercise Progression Protocol for LTGO

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Annette DeVito Dabbs
• Organization: University of Pittsburgh

ajdst42@pitt.edu

4126245314

Study Officials

• Annette DeVito Dabbs, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Model Details: 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.

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: November 2, 2018
• Study Start: April 1, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)