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

NCT00491309 | Unknown

• 1 other identifier: Reha PH Rheumatic
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Connective Tissue Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

  baseline, 3 weeks, 15 weeks

Study Arms (2)

exercise training group

ACTIVE COMPARATOR

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

Behavioral: exercise training

Control group without exercise training

NO INTERVENTION

continuation of sedentary lifestyle without advice for specific exercise training

Interventions

exercise training BEHAVIORAL

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

exercise training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent
• Men and women 18 - 80 years
• Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
• 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

You may not qualify if:

• Other forms of PAH.
• Pregnancy or lactation
• Change in medication during the last 2 ½ months
• Patients with signs of right heart decompensation
• Severe impairment of walking
• Unclear diagnosis
• No invasive diagnosis of PH
• Acute illness, infection, fever
• Severe lung disease with FEV1 \<50% and TLC\< 70% below reference

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 22709477 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Connective Tissue Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ekkehard Gruenig, MD

  Thoraxclinic at the University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekkehard Gruenig, MD

CONTACT

+49 6221 396 80 53; ekkehard.gruenig@thoraxklinik-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: July 1, 2011
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

DE (1)