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

Not Applicable

• Conditions: Pulmonary Hypertension; Connective Tissue Disease
• Interventions: Behavioral: exercise training

• Registration Number: NCT00491309
• Lead Sponsor: Heidelberg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Study Start: 2011-07
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise training group	exercise training	exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	baseline, 3 weeks, 15 weeks	echocardiography
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
change of NTproBNP-value	baseline, 3 weeks, 15 weeks

Trial Locations

Locations (1)

Thoraxclinic at the University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany