Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


Further study details as provided by Heidelberg University:

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: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
Investigators
Principal Investigator: Ekkehard Gruenig, MD Thoraxclinic at the University Hospital Heidelberg
  More Information

No publications provided by Heidelberg University

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, Heidelberg University
ClinicalTrials.gov Identifier: NCT00491309     History of Changes
Other Study ID Numbers: Reha PH Rheumatic
Study First Received: June 25, 2007
Last Updated: July 1, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on November 20, 2014