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

This study is currently recruiting participants.
Verified March 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00491309
First received: June 25, 2007
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  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 Phase
Pulmonary Hypertension
Connective Tissue Disease
 Behavioral: exercise training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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. ] [ Designated as safety issue: Yes ]
  • Quality of life (SF-36) [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]

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 [ 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 ]

Estimated Enrollment: 45
Study Start Date: July 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: exercise training group
exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training)
 Behavioral: exercise training
exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
No Intervention: Control group without exercise training
continuation of sedentary lifestyle without advice for specific exercise training

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
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 by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00491309     History of Changes
Other Study ID Numbers: Reha PH Rheumatic
Study First Received: June 25, 2007
Last Updated: March 9, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Connective Tissue Diseases
Hypertension
Hypertension, Pulmonary
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013