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

NCT ID: NCT00491309

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

exercise training group

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

Group Type: ACTIVE_COMPARATOR

exercise training

Intervention Type: BEHAVIORAL

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

Control group without exercise training

continuation of sedentary lifestyle without advice for specific exercise training

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

exercise training

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekkehard Gruenig, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxclinic at the University Hospital Heidelberg

Locations

Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ekkehard Gruenig, MD

Role: CONTACT

ekkehard.gruenig@thoraxklinik-heidelberg.de

+49 6221 396 80 53

References

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.

Reference Type: DERIVED

PMID: 22709477 (View on PubMed)

Other Identifiers

Reha PH Rheumatic

Identifier Type: -

Identifier Source: org_study_id