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Completed

NCT Number: NCT03728257

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

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.

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Key information

Conditions

Exercise Behavior Lung Transplantation Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: Baseline and 3 months

    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).

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

    Time frame: Baseline and 6 months

    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).

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

    Time frame: Baseline and 3 months.

    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).

  4. Physical Function- Balance: Change From Baseline to 6 Months

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

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

    Time frame: Baseline and 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).

Secondary outcomes

  1. Blood Pressure Control-Change From Baseline to 3months

    Time frame: Baseline and 3 months

    Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome.

  2. Blood Pressure Control-Change From Baseline to 6 Months

    Time frame: Baseline and 6 months.

    Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: LTGO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2018
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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