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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00491309
• Other study ID #: Reha PH Rheumatic
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: Ekkehard Gruenig, MD
• Phone: +49 6221 396 80 53
• Email: ekkehard.gruenig[@]thoraxklinik-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Disease
• Connective Tissue Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Behavioral:
• exercise training
exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)

Locations

Country	Name	City	State
Germany	Thoraxclinic at the University Hospital Heidelberg	Heidelberg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the 6-minute walking distance		after 3 weeks and after 15 weeks compared to baseline.
Primary	Quality of life (SF-36)		baseline and 15 weeks
Secondary	change in inflammatory parameters (BKS, CRP, Leucocytes), change in inflammatory cytokines (TNF-a), change in parameters of the vascular endothelium (Endothelin, PDGF, VEGF), and endothelial progenitor cells		baseline and 15 weeks
Secondary	Physical capacity in the cardiopulmonary exercise testing (Watt)		baseline, 3 weeks, 15 weeks
Secondary	change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.		baseline, 3 weeks, 15 weeks
Secondary	hemodynamic parameters: dimension and pump function of the right and the left ventricle.		baseline, 15 weeks
Secondary	change in systolic pulmonary arterial pressure at rest and during exercise	echocardiography	baseline, 3 weeks, 15 weeks
Secondary	change of NTproBNP-value		baseline, 3 weeks, 15 weeks