Mode
Text Size
Log in / Sign up
N/A N=88 Randomized Double-blind Treatment

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

Exercise · Lung Transplantation

Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Physical Function- Walking: Change in Average Steps Per Day at Month 3 — 460; 352 average steps per day — p=0.8793

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
LTGO-Home Based Exercise (Behavioral); Enhanced Usual Care (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pittsburgh
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Physical Function- Walking: Change in Average Steps Per Day at Month 3
460; 352 0.8793
PRIMARY
Physical Function- Walking: Change in Average Steps Per Day at Month 6
445; 405 0.9597
PRIMARY
Physical Function- Balance: Change in Berg Balance at Month 3
0.48; 0.67 0.30
PRIMARY
Physical Function- Balance: Change From Baseline to 6 Months
1.71; 0.74 0.81
PRIMARY
Physical Function-Lower Body Strength: Change From Baseline to 3 Months
0.964; 0.314 0.2262
PRIMARY
Physical Function-Lower Body Strength: Change From Baseline to 6 Months
1.5; 1.11 0.59
PRIMARY
Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.
-4.64; -6.45 0.26
PRIMARY
Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.
-6.33; -6.83 0.78
PRIMARY
Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.
2.18; 1.17 0.7073
PRIMARY
Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.
2.38; 6.53 0.313
SECONDARY
Blood Pressure Control-Change From Baseline to 3months
30; 31 0.91
SECONDARY
Blood Pressure Control-Change From Baseline to 6 Months
30; 24 0.72

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.

Eligibility Criteria

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.)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03728257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search