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

NCT01397110 | Unknown

• 1 other identifier: 2011-07-12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Changes in the maximum 6-minute walk distance (6MGT)

  up to 15 weeks

• Changes in quality of life

  up to 15 weeks

Secondary Outcomes (1)

• Changes in hemodynamics

  up to 15 weeks

Study Arms (2)

Respiratory and exercise therapy

ACTIVE COMPARATOR

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.

Other: respiratory and exercise therapy

Control group without exercise training

NO INTERVENTION

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.

Interventions

respiratory and exercise therapy OTHER

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

Respiratory and exercise therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed consent form
• men and women\> 18 years \<80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

: Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Eisenmenger Complex

Interventions

Respiratory Rate; Exercise Therapy

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Ekkehard Gruenig, MD

  Center for pulmonary hypertension, Thoraxclinic Heidelberg

  STUDY CHAIR

Central Study Contacts

Ekkehard Gruenig, MD

CONTACT

+49 6221 396 8053; ekkehard.gruenig@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 19, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

DE (1)