Post-Lung TransplantationINSPIRE-IIINCT04093869
Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
A study testing Coping Skills Training combined with Exercise (CSTEX) in people with Post-Lung Transplantation, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Lung Transplantation
- What is being tested?
- Coping Skills Training combined with Exercise (CSTEX)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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).
Read the 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
- Being tested
- Coping Skills Training combined with Exercise (CSTEX), Standard of Care plus Education (SOC-ED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Skills Training combined with Exercise (CSTEX)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coping Skills Training combined with Exercise (CSTEX) | Experimental | 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. Receives: Behavioral: Coping Skills Training combined with Exercise (CSTEX) |
| Standard of Care plus Education (SOC-ED) | Experimental | 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. Receives: Behavioral: Standard of Care plus Education (SOC-ED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Psychological Distress
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).
Measured: Baseline to 12 weeks
Secondary outcomes (10)
Change in Functional Capacity
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).
Measured: Baseline to 12 weeks
Change in Physical Activity
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).
Measured: Baseline to 12 weeks
Change in Sleep Quality
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).
Measured: Baseline to 12 weeks
Change in Quality of Life
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).
Measured: Baseline to 12 weeks
Change in Frailty
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).
Measured: Baseline to 12 weeks
Change in Problem-Focused Coping
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).
Measured: Baseline to 12 weeks
Change in Emotion-Focused Coping
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).
Measured: Baseline to 12 weeks
Change in Avoidant Coping
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).
Measured: Baseline to 12 weeks
Change in Self-Efficacy
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).
Measured: Baseline to 12 weeks
Chronic Lung Allograft Dysfunction (CLAD) Free Survival
Measured: Up to 3 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start6 Nov 2019
- Primary completion21 Feb 2024
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093869
- Sponsor's protocol ID
- Pro00100300
- Acronym
- INSPIRE-III
- Status last verified
- Feb 2026
- First submitted
- 6 Sep 2019
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40180232
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lung Transplant Outcomes With Coping Skills and Physical Activity
- ClinicalTrials.gov ID
- NCT04093869
- Acronym / sponsor ID
- INSPIRE-III / Pro00100300
- Conditions
- Post-Lung Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 4 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Skills Training combined with Exercise (CSTEX) | Experimental | Behavioral: 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. |
| Standard of Care plus Education (SOC-ED) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Coping Skills Training combined with Exercise (CSTEX) |
| 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. | Behavioural | Standard of Care plus Education (SOC-ED) |
Primary outcome
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).
10 secondary outcomes
Change in Functional Capacity
Time frame: Baseline to 12 weeks
Change in Physical Activity
Time frame: Baseline to 12 weeks
Change in Sleep Quality
Time frame: Baseline to 12 weeks
Change in Quality of Life
Time frame: Baseline to 12 weeks
Change in Frailty
Time frame: Baseline to 12 weeks
Change in Problem-Focused Coping
Time frame: Baseline to 12 weeks
Change in Emotion-Focused Coping
Time frame: Baseline to 12 weeks
Change in Avoidant Coping
Time frame: Baseline to 12 weeks
Change in Self-Efficacy
Time frame: Baseline to 12 weeks
Chronic Lung Allograft Dysfunction (CLAD) Free Survival
Time frame: Up to 3 years post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40180232Blumenthal 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.
- Individual participant dataSharing planned: No
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GVHD (Acute or Chronic)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Skills Training combined with Exercise (CSTEX) in people with Post-Lung Transplantation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Psychological Distress (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.