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

Heidelberg University1 site in 1 country45 target enrollmentJuly 2011

ConditionsPulmonary Hypertension Connective Tissue Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Hypertension
Sponsor: Heidelberg University
Enrollment: 45
Locations: 1
Primary Endpoint: Quality of life (SF-36)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2011

End Date

December 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Heidelberg University

Responsible Party

Principal Investigator

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Heidelberg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of life (SF-36)

Time Frame: baseline and 15 weeks

Change in the 6-minute walking distance

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

Secondary Outcomes

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(baseline, 3 weeks, 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)