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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, approximately 8 weeks, approximately 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in skeletal muscle O2 diffusive conductance (Dm) during supine cycle exercise

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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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