Connective Tissue Disease, Pulmonary Hypertension
Conditions
Brief summary
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.
Interventions
BEHAVIORALexercise training
exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent 2. Men and women 18 - 80 years 3. Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease) 4. 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
1. Other forms of PAH. 2. Pregnancy or lactation 3. Change in medication during the last 2 ½ months 4. Patients with signs of right heart decompensation 5. Severe impairment of walking 6. Unclear diagnosis 7. No invasive diagnosis of PH 8. Acute illness, infection, fever 9. Severe lung disease with FEV1 \<50% and TLC\< 70% below reference
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| change of NTproBNP-value | baseline, 3 weeks, 15 weeks | — |
| change in systolic pulmonary arterial pressure at rest and during exercise | baseline, 3 weeks, 15 weeks | echocardiography |
| Physical capacity in the cardiopulmonary exercise testing (Watt) | baseline, 3 weeks, 15 weeks | — |
Countries
Germany
Contacts
Primary ContactEkkehard Gruenig, MD
Outcome results
None listed