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Behavioral Intervention
Exercise Training for Pulmonary Arterial Hypertension
N/A
Recruiting
Led By Yogesh Reddy, M.B.B.S
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, approximately 8 weeks, approximately 12 weeks
Awards & highlights
Study Summary
This trial will test if whole body or isolated leg training is better for treating Pulmonary Arterial Hypertension (PAH) to improve symptoms & quality of life.
Who is the study for?
This trial is for adults with Pulmonary Arterial Hypertension (PAH) who are stable, not hospitalized recently, and haven't started new PAH drugs in the last 60 days. Healthy individuals without heart failure can also join as controls. Exclusions include recent severe cardiovascular events, inability to exercise, need for oxygen supplementation, pregnancy or potential pregnancy without effective contraception.Check my eligibility
What is being tested?
The study compares two types of physical training: whole body aerobic exercises versus targeted leg strength training. It aims to determine which method better improves symptoms and life quality in PAH patients.See study design
What are the potential side effects?
Since this trial involves exercise programs rather than medications, side effects may include muscle soreness or fatigue related to physical activity. However, these should be minimal compared to drug-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, approximately 8 weeks, approximately 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, approximately 8 weeks, approximately 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise
Secondary outcome measures
Change in Quality of Life as measured by the 36-Item Short-Form Survey (SF-36)
Change in Quality of Life as measured by the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) questionnaire
Change in Quality of Life as measured by the emPHasis-10 questionnaire
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Leg TrainingExperimental Treatment1 Intervention
Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo leg training for 12 weeks, and then repeat study assessments.
Group II: Aerobic TrainingActive Control1 Intervention
Subjects with PAH will be enrolled to complete baseline study assessments, be randomized to undergo aerobic training for 12 weeks, and then repeat study assessments.
Group III: Healthy ControlsActive Control1 Intervention
Healthy controls will be enrolled to complete the baseline study assessments for generation of normal reference values for comparison. Healthy controls will not undergo randomized exercise training interventions or repeat assessments.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,448 Total Patients Enrolled
12 Trials studying Pulmonary Arterial Hypertension
1,621 Patients Enrolled for Pulmonary Arterial Hypertension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,084 Total Patients Enrolled
25 Trials studying Pulmonary Arterial Hypertension
3,111 Patients Enrolled for Pulmonary Arterial Hypertension
Yogesh Reddy, M.B.B.SPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a heart attack, stroke, or heart-related hospitalization in the last 30 days, or you have certain heart conditions that could cause difficulty in breathing or exercising. You are unable to walk without assistance, have chronic low oxygen levels, have certain muscle or bone conditions, or have been involved in certain medical trials recently. You are pregnant, breastfeeding, or planning to become pregnant, or you have a severe psychiatric disorder, have had recent suicidal behavior, or are suspected of drug abuse.Criterion Summary:
For patients with Pulmonary Arterial Hypertension (PAH):
- You have given consent to participate in the trial.
- You are in NYHA Class II-IV.
- Your Left Ventricular Ejection Fraction (LVEF) is equal to or greater than 40% in the past year.
- You have not been hospitalized due to heart failure in the last 30 days.
- You have not started a new pulmonary vasodilator in the last 60 days.
- Your mean Pulmonary Arterial (PA) pressure is equal to or greater than 20 mmHg with Pulmonary Vascular Resistance (PVR) greater than 2 Wood units, as determined by right heart catheterization.
- Your exercise Pulmonary Capillary Wedge Pressure (PCWP) is less than 25 mm Hg.
- You are symptomatic with PAH and planning to undergo exercise right heart catheterization for reassessment of exertional symptoms.
For healthy controls:
- You have given consent to participate in the trial.
- You do not have a known diagnosis of heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic Training
- Group 2: Leg Training
- Group 3: Healthy Controls
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 new participants still being admitted into the clinical trial?
"As indicated on clinicaltrials.gov, this research is not currently seeking participants. It was first posted in August of 2023 and was last updated July twentieth of the same year. Although it isn't looking for volunteers at this time, there are 1,542 other studies actively recruiting patients presently."
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