Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Study Overview
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Brief Summary
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In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.

Official Title
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Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Conditions
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Pulmonary Hypertension, Connective Tissue Disease

Intervention / Treatment
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* Behavioral: exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Men and women 18 - 80 years Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease) Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation Mean pulmonary artery pressure (mPAP) > 25 mmHg Pulmonary capillary wedge pressure (PCWP) > 15 mmHg Pulmonary vascular resistance (PVR) at baseline >320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months Exclusion Criteria: Other forms of PAH. Pregnancy or lactation Change in medication during the last 2 ½ months Patients with signs of right heart decompensation Severe impairment of walking Unclear diagnosis No invasive diagnosis of PH Acute illness, infection, fever Severe lung disease with FEV1 <50% and TLC< 70% below reference

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: exercise training group<br>exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training) | Behavioral: exercise training<br>* exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)<br>|
| No Intervention: Control group without exercise training<br>continuation of sedentary lifestyle without advice for specific exercise training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the 6-minute walking distance |  | after 3 weeks and after 15 weeks compared to baseline. | 
| Quality of life (SF-36) |  | baseline and 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in inflammatory parameters (BKS, CRP, Leucocytes), change in inflammatory cytokines (TNF-α), change in parameters of the vascular endothelium (Endothelin, PDGF, VEGF), and endothelial progenitor cells |  | baseline and 15 weeks | 
| Physical capacity in the cardiopulmonary exercise testing (Watt) |  | baseline, 3 weeks, 15 weeks | 
| change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing. |  | baseline, 3 weeks, 15 weeks | 
| hemodynamic parameters: dimension and pump function of the right and the left ventricle. |  | baseline, 15 weeks | 
| change in systolic pulmonary arterial pressure at rest and during exercise | echocardiography | baseline, 3 weeks, 15 weeks | 
| change of NTproBNP-value |  | baseline, 3 weeks, 15 weeks |