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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
ClinicalTrials.gov Identifier:
NCT00491309
First received: June 25, 2007
Last updated: July 1, 2014
Last verified: July 2014

June 25, 2007
July 1, 2014
July 2011
December 2015   (final data collection date for primary outcome measure)
  • Change in the 6-minute walking distance [ Time Frame: after 3 weeks and after 15 weeks compared to baseline. ] [ Designated as safety issue: Yes ]
  • Quality of life (SF-36) [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]
  • Change in the 6-minute walking distance [ Time Frame: after 3 weeks and after 15 weeks compared to baseline. ]
  • Quality of life (SF-36)
Complete list of historical versions of study NCT00491309 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Physical capacity in the cardiopulmonary exercise testing (Watt) [ Time Frame: baseline, 3 weeks, 15 weeks ] [ Designated as safety issue: Yes ]
  • change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing. [ Time Frame: baseline, 3 weeks, 15 weeks ] [ Designated as safety issue: Yes ]
  • hemodynamic parameters: dimension and pump function of the right and the left ventricle. [ Time Frame: baseline, 15 weeks ] [ Designated as safety issue: Yes ]
  • change in systolic pulmonary arterial pressure at rest and during exercise [ Time Frame: baseline, 3 weeks, 15 weeks ] [ Designated as safety issue: Yes ]
    echocardiography
  • change of NTproBNP-value [ Time Frame: baseline, 3 weeks, 15 weeks ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Connective Tissue Disease
Behavioral: exercise training
exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
  • Active Comparator: exercise training group
    exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training)
    Intervention: Behavioral: exercise training
  • No Intervention: Control group without exercise training
    continuation of sedentary lifestyle without advice for specific exercise training
Grünig E, Maier F, Ehlken N, Fischer C, Lichtblau M, Blank N, Fiehn C, Stöckl 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Ekkehard Gruenig, MD +49 6221 396 80 53 ekkehard.gruenig@thoraxklinik-heidelberg.de
Germany
 
NCT00491309
Reha PH Rheumatic
No
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
Heidelberg University
Not Provided
Principal Investigator: Ekkehard Gruenig, MD Thoraxclinic at the University Hospital Heidelberg
Heidelberg University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP