Coping Skills and Physical Activity for Lung Transplant Recovery

(INSPIRE-III Trial)

Overseen By James A Blumenthal, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Malignancies, Pregnancy, Multi-organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help lung transplant recipients feel better and move more easily. It will compare a program combining coping skills and exercise (CSTEX) with standard care and transplant education (SOC-ED) to determine which approach reduces stress and enhances physical ability. Individuals who have had a single or double lung transplant, are at least six weeks post-surgery, and have completed a rehab program in the last 18 months may be suitable candidates. Participants will attend weekly sessions led by experts to guide them through the process. As an unphased trial, this study offers a unique opportunity to explore innovative methods for enhancing post-transplant recovery and improving quality of life.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it mentions that participants should be on a stable medication regimen. This suggests you may continue your current medications as long as they are stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Coping Skills Training combined with Exercise (CSTEX) is generally well-tolerated and beneficial for lung transplant patients. Studies indicate that regular exercise can speed up recovery after a lung transplant and may also address issues like high blood pressure. These findings suggest that the CSTEX approach, which includes exercise and learning coping skills, is safe and effective for aiding recovery and managing stress.

Although CSTEX is not a new drug or surgery, it involves activities known to be safe, such as exercise and mental health support. No serious side effects have been reported from these activities in the context of lung transplant recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for lung transplant recovery because they combine mental and physical health strategies in innovative ways. The Coping Skills Training combined with Exercise (CSTEX) program uniquely integrates motivational interviewing, Cognitive Behavioral Therapy (CBT), and exercise therapy, providing a holistic approach to recovery. Meanwhile, the Standard of Care plus Education (SOC-ED) focuses on empowering patients with knowledge through education, which can enhance adherence to post-transplant care. These approaches are different from traditional treatments, which typically prioritize medical care and medication, by addressing psychological and physical rehabilitation simultaneously.

What evidence suggests that this trial's treatments could be effective for lung transplant recovery?

Research has shown that combining Coping Skills Training with Exercise (CSTEX), which participants in this trial may receive, can reduce stress and improve the quality of life for lung transplant patients. Studies have found that exercise aids in faster physical recovery after a lung transplant. Additionally, learning better coping skills can alleviate stress. Together, these methods aim to enhance both physical and mental well-being after surgery. This combination is designed to support more effective recovery and increase patients' confidence in daily activities. Another group in this trial will receive Standard of Care plus Education (SOC-ED), which focuses on educational instruction to support recovery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 6 weeks post-lung transplant, on stable medications, completed pulmonary rehab in the last 18 months, and speak English. It's not for pregnant women, those unable to consent, multi-organ or repeat lung recipients, or with a life expectancy under 12 months due to other illnesses.

Inclusion Criteria

My current medications have not changed recently.

I finished lung rehab after a transplant within the last 18 months.

You can speak English well enough to understand and communicate during the study.

Exclusion Criteria

I have received multiple organ transplants or more than one lung transplant.

Current pregnancy

Inability to read or to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CSTEX or SOC-ED intervention consisting of 12 weekly sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Coping Skills Training combined with Exercise (CSTEX)
• Standard of Care plus Education (SOC-ED)

Trial Overview The study tests if coping skills training combined with exercise (CSTEX) can reduce distress and improve physical function after a lung transplant compared to standard care plus education (SOC-ED). Participants are randomly assigned to one of these two groups.

How Is the Trial Designed?

Group I: Standard of Care plus Education (SOC-ED) Experimental Treatment 1 Intervention

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 II: Coping Skills Training combined with Exercise (CSTEX) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

A 12-week tele-coaching intervention for lung transplant recipients was found to be feasible and well-accepted, with 86% of participants enjoying the program and no adverse events reported.

Participants in the tele-coaching group significantly increased their daily steps and movement intensity compared to the usual care group, indicating that this intervention can effectively enhance physical activity levels post-lung transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a physical activity behavioural modification tele-coaching intervention in lung transplant recipients. Hume, E., Muse, H., Wallace, K., et al.[2022]

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/69/NCT04093869/Prot_SAP_001.pdf

Improving Lung Transplant Outcomes with Coping Skills ... The study will aim to evaluate the effectiveness of the Coping Skills Training plus Exercise (CSTEX) intervention in reducing distress.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7056276/

Remote Therapy to Improve Outcomes in Lung Transplant ... Promoting regular exercise and enhancing coping skills are 2 approaches that have been shown to reduce psychological distress, improve QoL, and ...

3. withpower.com withpower.com/trial/phase-10-2019-e4bde

Coping Skills and Physical Activity for Lung Transplant Recovery ... This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce distress and ...

4. ctv.veeva.com ctv.veeva.com/study/improving-lung-transplant-outcomes-with-coping-skills-and-physical-activity

Improving Lung Transplant Outcomes With Coping Skills and ... This study evaluates the effectiveness of a coping skills and exercise (CSTEX) intervention among post lung transplant patients aimed to reduce ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8406964/

Exercise training for adult lung transplant recipients - PMC Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation.

6. journals.lww.com journals.lww.com/transplantationdirect/fulltext/2020/03000/remote_therapy_to_improve_outcomes_in_lung.6.aspx

Remote Therapy to Improve Outcomes in Lung Transplant... CSTEX, Coping Skills Training combined with Exercise. Promoting regular exercise and enhancing coping skills are 2 approaches that have been shown to reduce ...

7. researchgate.net researchgate.net/publication/353351664_Exercise_training_for_adult_lung_transplant_recipients

Exercise training for adult lung transplant recipients Evidence suggests that exercise training may contribute to speeding up physical recovery in adults undergoing lung transplantation, helping to ...

8. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-02882-5

Perceptions of barriers to and facilitators of exercise ... Numerous studies have demonstrated that exercise rehabilitation can alleviate secondary chronic transplant-related conditions like hypertension, ...