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

February 16, 2026 updated by: Duke University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Global Psychological Distress
Time Frame: Baseline to 12 weeks
A composite distress score will assess change from baseline to 12 weeks (post-intervention) and combine the following instruments: General Health Questionnaire, Perceived Stress Scale, Beck Depression Inventory-II, State Trait Anxiety Inventory, and PROMIS Anger. The composite distress score is the average of the participant's rank for change (from baseline to 12 weeks) on each of the 5 scales. A lower rank represents more improvement (decrease in global distress) and higher ranks represent less improvement (or worsening of distress). Scoring is based on the number of participants analyzed; in this case the possible score range is 1-180. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Capacity
Time Frame: Baseline to 12 weeks
Functional capacity will be measured by distance walked on a standard Six Minute Walk Test (6MWT) at baseline and again post-intervention at 12 weeks. Distance measured in feet. Greater distance represents better functional capacity. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Physical Activity
Time Frame: Baseline to 12 weeks
Daily physical activity (average steps per day) will be assessed via a wrist-worn activity monitor (Actigraph GT9X Link) for 7 consecutive days at baseline and again post-intervention at 12 weeks. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Sleep Quality
Time Frame: Baseline to 12 weeks
Sleep quality (average total minutes of sleep per night) will be assessed via the Pittsburgh Sleep Quality Index at baseline and again post-intervention at 12 weeks. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Quality of Life
Time Frame: Baseline to 12 weeks
Quality of Life will be assessed via the Lung Transplant Quality of Life Survey, which is comprised of 10 scales that measure symptoms, health perceptions, functioning, and well being at baseline and again post-intervention at 12 weeks. The QOL overall score ranges from 1 to 5, with a higher score indicating worse health. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Frailty
Time Frame: Baseline to 12 weeks
Frailty will be measured by performance on the Fried Frailty Index. This assessment includes measures on patient's weight, exhaustion level, physical activity, walking speed, and hand grip strength at baseline and again post-intervention at 12 weeks. Scores range from 0 to 5, with lower scores indicating less frailty. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Problem-Focused Coping
Time Frame: Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher average score within the problem-focused subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Emotion-Focused Coping
Time Frame: Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A higher score within the emotion-focused coping subscale indicates better coping strategies. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Avoidant Coping
Time Frame: Baseline to 12 weeks
Coping was assessed via the Brief COPE Inventory, which is composed of scales that measure problem-focused coping, emotion-focused coping, and avoidant coping responses at baseline and again post-intervention at 12 weeks. Items are scored on a 4-point Likert scale, with 1 indicating a coping mechanism that the participant has not been doing at all, to 4 indicating a coping mechanism in which the participant has been doing a lot. A lower score within the avoidant coping subscale indicates a more useful coping strategy. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Change in Self-Efficacy
Time Frame: Baseline to 12 weeks
Self-efficacy will be assessed via the General Self-Efficacy Scale, which is a 10-item scale that measures emotional distress at baseline and again post-intervention at 12 weeks. Scores range from 10-40 with a higher score indicating better self-efficacy. The change value is calculated as T2 (12 weeks) - T1 (baseline).
Baseline to 12 weeks
Chronic Lung Allograft Dysfunction (CLAD) Free Survival
Time Frame: Up to 3 years post-treatment
Up to 3 years post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00100300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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