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	No
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.	Interventional
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.	NCT00491309
Phase 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.	N/A
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.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Connective Tissue Disease

Arms & Interventions

Arms

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

Interventions

Behavioral: - exercise training

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.