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

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the treatment Coping Skills Training combined with Exercise (CSTEX) for lung transplant recovery?

Exercise training has been shown to improve exercise capacity and quality of life in lung transplant patients, and strategies to increase physical activity and reduce emotional distress are needed to enhance recovery. While direct evidence for CSTEX is limited, exercise and coping skills are beneficial components for improving outcomes in lung transplant recipients. ^{1 2 3 4 5}

Is the combination of coping skills training and exercise safe for lung transplant recovery?

Research shows that exercise programs, including those delivered remotely, are generally safe for lung transplant recipients, with no reported adverse events. These programs have been found to be feasible and acceptable, improving physical function and activity levels. ^{1 2 3 4 6}

How does the CSTEX treatment differ from other treatments for lung transplant recovery?

The CSTEX treatment is unique because it combines coping skills training with exercise to address both emotional distress and physical inactivity, which are common issues after lung transplantation. This dual approach aims to improve quality of life and functional capacity, unlike standard treatments that may focus solely on medical management or physical rehabilitation. ^{1 2 3 4 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Remote Therapy to Improve Outcomes in Lung Transplant Recipients: Design of the INSPIRE-III Randomized Clinical Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Exercise training for lung transplant candidates and recipients: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a physical activity behavioural modification tele-coaching intervention in lung transplant recipients. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation in Patients before and after Lung Transplantation. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Psychosocial issues facing lung transplant candidates, recipients and family caregivers. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Delivering an in-Home Exercise Program via Telerehabilitation: A Pilot Study of Lung Transplant Go (LTGO). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Cross-sectional assessment of daily physical activity in chronic obstructive pulmonary disease lung transplant patients. [2022]