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

This study is currently recruiting participants.

Verified by University of Heidelberg, May 2007

First Received: June 25, 2007 Last Updated: July 1, 2008 History of Changes

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00491309

Purpose

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.

Condition	Intervention
Pulmonary Hypertension Exercise	Behavioral: Exercise and Respiratory Therapy

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Change in the 6-minute walking distance [ Time Frame: after 3 weeks and after 15 weeks compared to baseline. ]
Quality of life (SF-36)

Secondary Outcome Measures:

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
Physical capacity in the cardiopulmonary exercise testing (Watt)
change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.
hemodynamic parameters: dimension and pump function of the right and the left ventricle.
change in systolic pulmonary arterial pressure at rest and during exercise
change in strength of respiratory muscles
change of MRI-parameters
change of NTproBNP-value

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491309

Contacts

Contact: Ekkehard Gruenig, MD

+49 6221 396 80 53

ekkehard.gruenig@thoraxklinik-heidelberg.de

Locations

Germany, Baden-Wuerttemberg
Thoraxclinic at the University Hospital Heidelberg	Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Principal Investigator: Ekkehard Gruenig, MD

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Ekkehard Gruenig, MD

Thoraxclinic at the University Hospital Heidelberg

More Information

No publications provided

Study ID Numbers:	Reha PH Rheumatic
Study First Received:	June 25, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00491309 History of Changes
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Autoimmune Diseases
Respiratory Tract Diseases
Musculoskeletal Diseases
Hypertension, Pulmonary
Lung Diseases
Joint Diseases

Arthritis
Vascular Diseases
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Hypertension

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Vascular Diseases
Rheumatic Diseases
Respiratory Tract Diseases

Musculoskeletal Diseases
Hypertension, Pulmonary
Arthritis
Lung Diseases
Connective Tissue Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009