Exercise and respiratory therapy for pulmonary hypertension
Influence of Breath- and Movementtherapy to Clinical and Molecular Parameter in Patients With Pulmonary Hypertension
This study tests if adding exercise and breathing therapy can help people with pulmonary hypertension feel better and improve their quality of life while they are already on medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heidelberg University Academic / other |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04224025 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of additional exercise and respiratory therapy on patients with pulmonary hypertension who are already receiving optimized medical treatment. It is a prospective, randomized, controlled trial that aims to assess both clinical and molecular parameters to evaluate the effectiveness of the training. Key measurements include hemodynamic assessments, exercise capacity, quality of life, and safety evaluations through routine examinations and structured interviews. The study will be conducted at the Thoraxklinik Heidelberg, focusing on improving patient outcomes through a comprehensive approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with symptomatic pulmonary hypertension who have been on stable optimized treatment for at least two months.
Not a fit: Patients with severe walking problems, acute illnesses, or significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of life and physical efficiency of patients with pulmonary hypertension.
How similar studies have performed: Other studies have shown promising results with exercise interventions in pulmonary hypertension, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consent form * Men and women \>18 years * Symptomatic PH (WHO-FC II-IV) invasive diagnostis with right heart catheterization: mPAP \>25mmHg and a stable optimized treatment for at least 2 month * Patients who are able to understand and agree to participate in the study Exclusion Criteria: * Pregnancy or breast feeding * Variation in the medication during the last 2 months * Patients with signs of right heart decompensation * Major walking problems * Unclear diagnosis * No invasive clarification of the PH * Acute illness, infections and fever * Grave lung disease with FEV1 \<50% or TLC \<70% from target * Further conclusion criteria are followed: acrive myokarditis, unstable angina pectoris, movement induced ventricular rhythmdisturbance, decompensation of the right hart insufficiency, meaningful heartvitien, hyperthrophic obstructive cardiomyopathie or a high grade reduced left ventricular pump function * Acute psychosis or other conditions which appears a reduced understanding * Patiets with metallic valvular or other metallic implants * Incorporated ferromagnetic materials or for the MRI incompatibel activce medicinal products * Claustrophobia
Where this trial is running
Heidelberg
- Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital — Heidelberg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.