Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Study Overview
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Brief Summary
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Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.

Official Title
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Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Other: respiratory and exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent form men and women> 18 years <75 years invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable. Exclusion Criteria: Pregnancy or lactation Change in medication during the last 2 months Patients with signs of right heart decompensation severe walking disturbance uncertain diagnoses No previous invasively confirmation of PH acute diseases, infections, fever Serious lung disease with FEV1 <50% or TLC <70% of target Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory and exercise therapy<br>Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group. | Other: respiratory and exercise therapy<br>* Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training<br>|
| No Intervention: respiratory and exercise therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of peak O2 uptake (VO2peak) under stress | Three-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group. | up to 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemodynamics at rest and during exercise | Changes in hemodynamics at rest and during exercise after three weeks and 15 weeks: RAP, RVP, sPAP, DPAP, mPAP, PCWP, cardiac output, PVR, CI, SvO2 Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2) Improved condition(NYHA class, Borg scale) Changes in MRI and echocardiographic parameters of right and left ventricle: size and pump function. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins | up to 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiratory therapy, exercise therapy, oxygen uptake, quality of life, right ventricular function, severe pulmonary hypertension