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

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: Completed
• Conditions: Post-Lung Transplantation
• Intervention / Treatment: Behavioral: Coping Skills Training combined with Exercise (CSTEX); Behavioral: Standard of Care plus 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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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).	Baseline to 12 weeks
Chronic Lung Allograft Dysfunction (CLAD) Free Survival		Up to 3 years post-treatment

Collaborators and Investigators

• Sponsor: Duke University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): February 21, 2024
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality of Health Care; Quality Indicators, Health Care; Socioeconomic Factors; Population Characteristics; Exercise; Standard of Care; Educational Status
• Other Study ID 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