Clinical trial NCT00491309: Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
Official title: Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Connective Tissue Disease
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the 6-minute walking distance
timeFrame: after 3 weeks and after 15 weeks compared to baseline.
measure: Quality of life (SF-36)
timeFrame: baseline and 15 weeks
Secondary outcomes:
measure: 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
timeFrame: baseline and 15 weeks
measure: Physical capacity in the cardiopulmonary exercise testing (Watt)
timeFrame: baseline, 3 weeks, 15 weeks
measure: change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.
timeFrame: baseline, 3 weeks, 15 weeks
measure: hemodynamic parameters: dimension and pump function of the right and the left ventricle.
timeFrame: baseline, 15 weeks
measure: change in systolic pulmonary arterial pressure at rest and during exercise
timeFrame: baseline, 3 weeks, 15 weeks
measure: change of NTproBNP-value
timeFrame: baseline, 3 weeks, 15 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxclinic at the University Hospital Heidelberg
state: Baden-Wuerttemberg
Study officials:
affiliation: Thoraxclinic at the University Hospital Heidelberg
name: Ekkehard Gruenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grunig E, Maier F, Ehlken N, Fischer C, Lichtblau M, Blank N, Fiehn C, Stockl F, Prange F, Staehler G, Reichenberger F, Tiede H, Halank M, Seyfarth HJ, Wagner S, Nagel C. Exercise training in pulmonary arterial hypertension associated with connective tissue diseases. Arthritis Res Ther. 2012 Jun 18;14(3):R148. doi: 10.1186/ar3883.