NCT03728257: LTGO

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

Completed NA Results posted Last updated 21 October 2024

What this trial tests

NA trial testing LTGO-Home Based Exercise in Exercise in 88 participants. Completed in 30 September 2023.

Timeline

1 April 2019

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	88
Start date	1 April 2019
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

• LTGO-Home Based Exercise
• Enhanced Usual Care

Conditions studied

• Exercise — all drugs for Exercise →
• Lung Transplantation — all drugs for Lung Transplantation →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with Exercise or Lung Transplantation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Physical Function- Walking: Change in Average Steps Per Day at Month 3 Primary · 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).

Group	Value	95% CI
LTGO-Home Based Exercise	460	± 3410
Enhanced Usual Care	352	± 2470

Physical Function- Walking: Change in Average Steps Per Day at Month 6 Primary · 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).

Group	Value	95% CI
LTGO-Home Based Exercise	445	± 2310
Enhanced Usual Care	405	± 3570

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

Group	Value	95% CI
LTGO-Home Based Exercise	0.48	± 1.96
Enhanced Usual Care	0.67	± 1.67

Physical Function- Balance: Change From Baseline to 6 Months Primary · 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).

Group	Value	95% CI
LTGO-Home Based Exercise	1.71	± 3.29
Enhanced Usual Care	0.74	± 1.73

Physical Function-Lower Body Strength: Change From Baseline to 3 Months Primary · 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 sc

Group	Value	95% CI
LTGO-Home Based Exercise	0.964	± 2.03
Enhanced Usual Care	0.314	± 2.18

Physical Function-Lower Body Strength: Change From Baseline to 6 Months Primary · 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 s

Group	Value	95% CI
LTGO-Home Based Exercise	1.5	± 2.53
Enhanced Usual Care	1.11	± 3.29

Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months. Primary · 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).

Group	Value	95% CI
LTGO-Home Based Exercise	-4.64	± 9.29
Enhanced Usual Care	-6.45	± 11.56

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

Group	Value	95% CI
LTGO-Home Based Exercise	-6.33	± 11.26
Enhanced Usual Care	-6.83	± 8.38

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

Group	Value	95% CI
LTGO-Home Based Exercise	2.18	± 7.37
Enhanced Usual Care	1.17	± 13.0

Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months. Primary · 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 min

Group	Value	95% CI
LTGO-Home Based Exercise	2.38	± 9.99
Enhanced Usual Care	6.53	± 21.6

Blood Pressure Control-Change From Baseline to 3months Secondary · 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.

Group	Value	95% CI
LTGO-Home Based Exercise	30
Enhanced Usual Care	31

Blood Pressure Control-Change From Baseline to 6 Months Secondary · 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.

Group	Value	95% CI
LTGO-Home Based Exercise	30
Enhanced Usual Care	24

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exercise training for adult lung transplant recipients.
   Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, et al · · 2021 · cited 13× · PMID 34282853 · DOI 10.1002/14651858.cd012307.pub2
2. Considerations for assessing physical function and physical activity in clinical trials during the COVID-19 pandemic.
   Moon SJE, Dabbs AD, Hergenroeder AL, Vendetti ML, et al · · 2021 · cited 11× · PMID 33887443 · DOI 10.1016/j.cct.2021.106407
3. Exploring Factors Associated with Sleep Quality After Lung Transplantation.
   Moon SJE, Kazakoff M, Jones KB, Abdul H, et al · · 2025 · PMID 40552381 · DOI 10.1177/15269248251349770
4. The Association Between Patient-Level Factors and Physical Function in Lung Transplant Recipients.
   Alemairi M, Hergenroeder A, Ren D, DeVito Dabbs A. · · 2024 · PMID 39830998 · DOI 10.1097/cpt.0000000000000253