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

Heidelberg University45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension Connective Tissue Disease

Interventions

exercise trainingBEHAVIORAL

exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

RECRUITING

Outcomes

Primary Outcomes

Change in the 6-minute walking distance

Time frame: after 3 weeks and after 15 weeks compared to baseline.

Quality of life (SF-36)

Time frame: baseline and 15 weeks

Secondary Outcomes

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

Time frame: baseline and 15 weeks

Physical capacity in the cardiopulmonary exercise testing (Watt)

Time frame: baseline, 3 weeks, 15 weeks

change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.

Time frame: baseline, 3 weeks, 15 weeks

hemodynamic parameters: dimension and pump function of the right and the left ventricle.

Time frame: baseline, 15 weeks

change in systolic pulmonary arterial pressure at rest and during exercise

echocardiography

Time frame: baseline, 3 weeks, 15 weeks

change of NTproBNP-value

Time frame: baseline, 3 weeks, 15 weeks

Central Contacts

Ekkehard Gruenig, MD

CONTACT

+49 6221 396 80 53 ekkehard.gruenig@thoraxklinik-heidelberg.de

Data from ClinicalTrials.gov

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