N/A
N=180
Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
Post-Lung Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT04093869 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Global Psychological Distress — 91; 87 units on a scale — p=0.40
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coping Skills Training combined with Exercise (CSTEX) (Behavioral); Standard of Care plus Education (SOC-ED) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Psychological Distress |
91; 87 | 0.40 |
| SECONDARY Change in Functional Capacity |
1451; 1472 | — |
| SECONDARY Change in Physical Activity |
8037; 8612 | — |
| SECONDARY Change in Sleep Quality |
421; 401 | — |
| SECONDARY Change in Quality of Life |
1.78; 1.78 | — |
| SECONDARY Change in Frailty |
0.62; 0.52 | — |
| SECONDARY Change in Problem-Focused Coping |
2.64; 2.73 | — |
| SECONDARY Change in Emotion-Focused Coping |
2.26; 2.25 | — |
| SECONDARY Change in Avoidant Coping |
1.45; 1.46 | — |
| SECONDARY Change in Self-Efficacy |
33.3; 33.1 | — |
| SECONDARY Chronic Lung Allograft Dysfunction (CLAD) Free Survival |
— | — |
Summary
This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and improve functional capacity. Half of the patients will receive CSTEX and half will receive the standard of care plus transplant education (SOC-ED).
Eligibility Criteria
Inclusion Criteria
- Single or bilateral first lung transplant recipient; discharged from the hospital and at least 6 weeks post-transplant; completed post-transplant pulmonary rehabilitation within the past 18 months; on stable medication regimen; proficient in the English language
Exclusion Criteria
- Illness such as malignancies that are associated with a life-expectancy of < 12 months; current pregnancy; inability to read or to provide informed consent; multi-organ transplant recipient or repeat lung transplant.
Data sourced from ClinicalTrials.gov (NCT04093869). 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.