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Coping Skills and Physical Activity for Lung Transplant Recovery (INSPIRE-III Trial)
N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Single or bilateral first lung transplant recipient
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-treatment
Awards & highlights
INSPIRE-III Trial Summary
This trial will test whether a coping skills and exercise intervention can help reduce distress and improve functional capacity for post-lung transplant patients.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since CSTEX involves non-medical interventions like exercise and psychological training, side effects may include typical exercise-related issues such as muscle soreness or strain. Psychological support is generally low-risk but could potentially bring up emotional discomfort.
INSPIRE-III Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received a lung transplant.
INSPIRE-III Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Global Psychological Distress
Changes in Functional Capacity
Secondary outcome measures
Changes in Physical Activity
Changes in Quality of Life
Changes in Sleep Quality
+1 moreINSPIRE-III Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard of Care plus Education (SOC-ED)Experimental Treatment1 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 Treatment1 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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,042 Total Patients Enrolled
3 Trials studying Lung Transplant
307 Patients Enrolled for Lung Transplant
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My current medications have not changed recently.I have received multiple organ transplants or more than one lung transplant.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.I was discharged from the hospital and it's been over 6 weeks since my transplant.I have received a lung transplant.My doctor expects me to live more than 12 months despite my illness.
Research Study Groups:
This trial has the following groups:- Group 1: Coping Skills Training combined with Exercise (CSTEX)
- Group 2: Standard of Care plus Education (SOC-ED)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the scope of individuals participating in this clinical trial?
"Indeed, information on clinicaltrials.gov indicates that this is an ongoing trial with recruitment beginning November 6th 2019 and most recently updated on March 17th 2022. The team needs 180 patients to be enrolled from 1 medical site."
Answered by AI
Are there any available vacancies in this clinical trial for volunteers?
"According to clinicaltrials.gov, this trial has been open since November 6th 2019 and is still actively seeking participants; the study was last modified on March 17th 2022."
Answered by AI
What is the purpose of this research endeavor?
"This trial, which will be evaluated over a Baseline; 12 weeks period, is primarily assessing Functional Capacity. Secondary outcomes evaluate Daily Physical Activity (using an Actigraph GT9X Link), Sleep Quality (via the Pittsburgh Sleep Quality Index), and Quality of Life (through the Lung Transplant Quality of Life Survey)."
Answered by AI
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