Improving Lung Transplant Outcomes With Coping Skills and Physical Activity (INSPIRE-III)

  • STATUS
    Recruiting
  • End date
    Jun 26, 2026
  • participants needed
    180
  • sponsor
    Duke University
Updated on 26 April 2022

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).

Description

The study will aim to evaluate the effectiveness of the CSTEX intervention in (i) reducing distress and (ii) improving functional capacity. It is hypothesized that compared to SOC-ED, the CSTEX intervention will result in 1) greater reductions in global distress measured by an established psychometric test battery; and 2) greater improvements in functional capacity assessed by distance walked on a standard Six Minute Walk test (6MWT).

Details
Condition Post-Lung Transplantation
Treatment Coping Skills Training combined with Exercise (CSTEX), Standard of Care plus Education (SOC-ED)
Clinical Study IdentifierNCT04093869
SponsorDuke University
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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