Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects

Heidelberg University

Status: Enrolling

Conditions: Eisenmenger Syndrome; Pulmonary Arterial Hypertension

Treatments: Other: respiratory and exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01397110

2011-07-12

Details and patient eligibility

About

The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signed consent form
• men and women> 18 years <80 years
• APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

Exclusion criteria

• Pregnancy or lactation
• Change in medication during the last 2 months
• severe walking disturbance
• uncertain diagnoses
• No previous invasively confirmation of PH
• acute diseases, infections, fever
• Serious lung disease with FEV1 <50% or TLC <70% of target
• Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Respiratory and exercise therapy

Active Comparator group

Description:

Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.

Treatment:

Other: respiratory and exercise therapy

Control group without exercise training

No Intervention group

Description:

patients of the control group continue their sedentary lifestyle without given advice for exercise training. The time before start of rehabilitation (three months) serves as control group. Afterwards patients take part in the training program as well.