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

NCT ID: NCT01397110

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension; Eisenmenger Syndrome

Study Design

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

Study Groups

Respiratory and exercise therapy

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.

Group Type: ACTIVE_COMPARATOR

respiratory and exercise therapy

Intervention Type: OTHER

Conventional therapy with specific respiratory and physical therapy plus mental walking training

Control group without exercise training

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

respiratory and exercise therapy

Conventional therapy with specific respiratory and physical therapy plus mental walking training

Intervention Type: OTHER

Eligibility Criteria

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

• 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: STUDY_CHAIR

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Locations

: Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ekkehard Gruenig, MD

Role: CONTACT

ekkehard.gruenig@med.uni-heidelberg.de

+49 6221 396 8053

Other Identifiers

2011-07-12

Identifier Type: -

Identifier Source: org_study_id