N/A
N=88
Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
Exercise · Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT03728257 ↗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
| Outcome | Result | p-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.)
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.