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

Heidelberg University

Status: Enrolling

Conditions: Connective Tissue Disease; Pulmonary Hypertension

Treatments: Behavioral: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT00491309

Reha PH Rheumatic

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

exercise training group

Active Comparator group

Description:

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

Treatment:

Behavioral: exercise training

Control group without exercise training

No Intervention group

Description:

continuation of sedentary lifestyle without advice for specific exercise training