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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Heidelberg University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ekkehard Gruenig, MD
Principal Investigator Affiliation Thoraxclinic at the University Hospital Heidelberg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Germany

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension, Connective Tissue Disease
Arms & Interventions


Active Comparator: exercise training group

exercise and respiratory therapy with specific program for pulmonary hypertension (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


Behavioral: - exercise training

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

Contact a Trial Team

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International Sites

Heidelberg, Baden-Wuerttemberg, Germany




Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wuerttemberg, 69126

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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