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Behavioral Intervention
Home-Based Exercise for Pulmonary Hypertension (PaRTAkE-PH Trial)
N/A
Waitlist Available
Led By Thomas Cascino, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Competent to give informed consent
Diagnosis of group 1 Pulmonary Atrial Hypertension (PAH) diagnosed during right heart catheterization (RHC) according to WHO criteria 28
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PaRTAkE-PH Trial Summary
This trial will test if a home-based exercise program can help improve exercise tolerance and physical activity for people with pulmonary arterial hypertension.
Who is the study for?
This trial is for individuals with stable Pulmonary Arterial Hypertension (PAH) who've had consistent treatment for at least 3 months. They should be able to follow up at the University of Michigan Hospital Centers for a year, have internet access, and not exercise regularly already. Excluded are those severely limited in physical activity, with life expectancy under a year or severe lung disease.Check my eligibility
What is being tested?
The study is examining whether a home-based exercise program can improve how far patients with PAH can walk and their overall physical activity compared to usual care without this program. Participants will either continue their normal routine or start the new exercise regimen.See study design
What are the potential side effects?
Since this trial involves an exercise program rather than medication, side effects may include muscle soreness, fatigue, or breathlessness during activities. Serious risks might involve heart-related events due to increased physical exertion.
PaRTAkE-PH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can agree to the study's procedures and risks.
Select...
I have been diagnosed with a specific type of high blood pressure in the lungs.
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My heart condition mildly to moderately affects my daily activities.
PaRTAkE-PH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in physical activity as measured by daily activity captured using the pedometer step count
Efficacy of a home-based exercise training as measured by change in World Health Organization (WHO) functional class
Efficacy of a home-based exercise training as measured by change in six-minute walk distance
+5 moreOther outcome measures
Change in echocardiographic assessment of right ventricle function
Change in echocardiographic assessment of right ventricle size
Change in heart rate recovery
+11 morePaRTAkE-PH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based exercise programExperimental Treatment1 Intervention
Home-based individualized exercise program based on heart rate reserve (HRR).
Group II: Usual CareActive Control1 Intervention
Usual care administered at the Pulmonary Arterial Hypertension (PAH) clinic at the University of Michigan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home-based exercise program
2021
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,800 Previous Clinical Trials
6,379,086 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
156 Patients Enrolled for Pulmonary Arterial Hypertension
ActelionIndustry Sponsor
191 Previous Clinical Trials
35,639 Total Patients Enrolled
66 Trials studying Pulmonary Arterial Hypertension
15,931 Patients Enrolled for Pulmonary Arterial Hypertension
Thomas Cascino, MDPrincipal InvestigatorUniversity of Michigan
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and can agree to the study's procedures and risks.My lung function tests show severe breathing obstruction.My PAH treatment has been the same for the last 3 months.I have health conditions that severely limit my physical activity.I've been on stable medications for 3 months in a clinical trial's extension stage.My oxygen levels drop below 88% during a 6-minute walk test or below 80% due to a heart issue.I have been diagnosed with a specific type of high blood pressure in the lungs.I can walk less than 150 meters or more than 550 meters in six minutes.You are expected to live less than 1 year.My lung capacity is less than 60% of what is expected.You have fainted or experienced irregular heartbeats during exercise in the past.I do not speak English.You have exercised for at least 30 minutes on one day each week for the past 3 months.You are currently misusing drugs or alcohol, or have a serious mental illness that makes it hard for you to follow the study rules.My heart condition mildly to moderately affects my daily activities.I have recently completed, am currently in, or plan to enroll in a lung rehab program within 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Home-based exercise program
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.
Are there any open slots left in this clinical research?
"According to data on clinicaltrials.gov, this particular medical trial is not currently enrolling participants as it was last updated on November 17th 2022. Nonetheless, there are 763 other trials actively recruiting at the moment."
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