Improving Lung Transplant Outcomes With Coping Skills and Physical Activity

NCT ID: NCT04093869

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2026-02-28

Brief 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).

Detailed 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).

Conditions

Post-Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Coping Skills Training combined with Exercise (CSTEX)

The CSTEX intervention will consist of 12, 30 minute weekly sessions conducted by a respiratory therapist knowledgeable about lung transplantation and trained in motivational interviewing, Cognitive Behavioral Therapy (CBT), and exercise therapy.

Group Type: EXPERIMENTAL

Coping Skills Training combined with Exercise (CSTEX)

Intervention Type: BEHAVIORAL

The CSTEX condition has two integrated components: the CST component will systematically train patients in the use of coping skills for stress reduction and promote key transplant-specific health behaviors. The exercise component of the intervention will progressively increase participants exercise and promote daily physical activity through motivational interviewing strategies.

Standard of Care plus Education (SOC-ED)

The SOC-ED intervention will consist of 12, 30 minute weekly sessions conducted by a health educator knowledgeable about transplantation and skilled in educational instruction.

Group Type: EXPERIMENTAL

Standard of Care plus Education (SOC-ED)

Intervention Type: BEHAVIORAL

The SOC-ED condition provides support and enhanced post-transplant education. Participants will be given detailed educational information about post-transplant care, the importance of medication adherence, and maintenance of physical activity.

Interventions

Coping Skills Training combined with Exercise (CSTEX)

The CSTEX condition has two integrated components: the CST component will systematically train patients in the use of coping skills for stress reduction and promote key transplant-specific health behaviors. The exercise component of the intervention will progressively increase participants exercise and promote daily physical activity through motivational interviewing strategies.

Intervention Type: BEHAVIORAL

Standard of Care plus Education (SOC-ED)

The SOC-ED condition provides support and enhanced post-transplant education. Participants will be given detailed educational information about post-transplant care, the importance of medication adherence, and maintenance of physical activity.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

Blumenthal JA, Mabe S, Arthur D, Frankel C, McKee DC, Morrison S, Sherwood A, Snyder LD, Palmer SM; INSPIRE III Investigators. Telehealth interventions to improve outcomes in lung transplant recipients: Primary results of the INSPIRE-III randomized clinical trial. J Heart Lung Transplant. 2025 Sep;44(9):1449-1459. doi: 10.1016/j.healun.2025.03.017. Epub 2025 Apr 1.

Reference Type: DERIVED

PMID: 40180232 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00100300

Identifier Type: -

Identifier Source: org_study_id