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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Connective Tissue Disease
• Intervention / Treatment: Behavioral: exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ekkehard Gruenig, MD; Phone Number: +49 6221 396 80 53; Email: ekkehard.gruenig@thoraxklinik-heidelberg.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		baseline and 15 weeks
Physical capacity in the cardiopulmonary exercise testing (Watt)		baseline, 3 weeks, 15 weeks
change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.		baseline, 3 weeks, 15 weeks
hemodynamic parameters: dimension and pump function of the right and the left ventricle.		baseline, 15 weeks
change in systolic pulmonary arterial pressure at rest and during exercise	echocardiography	baseline, 3 weeks, 15 weeks
change of NTproBNP-value		baseline, 3 weeks, 15 weeks

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 25, 2007
• First Submitted That Met QC Criteria: June 25, 2007
• First Posted (Estimate): June 26, 2007

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Connective Tissue Diseases
• Other Study ID Numbers: Reha PH Rheumatic