Training Single Arm

Pulmonary Hypertension Clinical Trial

Official title:

Influence of Breath- and Movementtherapy to Clinical and Molecular Parameter in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224025
• Other study ID #: Training single arm
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2015
• Est. completion date: December 2025

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pulmonary hypertension is a disease, which tends to a progredient right heart failure. Although there was a large progress in development of medical therapy, the quality of life, the physical efficiency and the prognosis of the patients are still limited. The aim of the study is to examine the influence of physical training to clinical and molecular parameter.

Description:

The aim of this prospective, randomized, controlled study in patients with pulmonary hypertension, who are under stable optimized treatment for at least 2 months, is to examine the effect of an additional exercise and respiratory therapy.

The aim criteria measures the clinical parameters to record the effect of the training plus molecular parameter to evaluate the effectiveness of the training. The molecular parameters are composed of laboratory parameter and inflammatory parameter as well as genetic analyses, measurements of epigenetic changes measured by microRNA Expressions and DNA-methylation.

The study parameters will be assessed in the patient's routine examinations. Clinical parameters comprise of hemodynamic assessment of pulmonary arterial pressure during exercise, pump function of left and right ventricle, and further echocardiographic parameters. Improvement of exercise capacity will be measured by the change of six-minute walking distance, the breathing economics, the world health organization functional class (WHO functional class), peak oxygen consumption and blood gas analysis. The quality of life will be assessed with the SF-36 questionnaire. Data for survival analysis will be gained by structured phone interviews . The safety of the training is warranted by long-term, rest- and stress-ECG, safety laboratory, systemic blood pressure, heart frequency, oxygen saturation and occurrence of adverse events.

Patients will be examined in the Thoraxklinik Heidelberg. Patients of the training group will take part in a specific, 3-week inpatient training program at the rehabilitation center Königstuhl Heidelberg. The training program consists of exercise and respiratory therapy as well as a mental gait training. Respiratory therapy will be performed 5 times/week for 30 minutes. Furthermore, 15-25 minutes low dosed interval training on a bicycle ergometer, dumbbell training of particular muscle groups with low weights and supervised walks on ground-level will be scheduled 5-7 times/week. Three- to five times a week a "mental gait training" is conducted to estimate the patient's individual physical abilities and limitations. The heart rate during exerciseand the intensity of the training will be closely monitored and individually adjusted. After three weeks of in-hospital rehabilitation the patients are asked to continue the training for twelve further weeks at home. All patients will be examined before the training program, at the end of the in-hospital phase after three weeks and after 15 weeks.

The control examinations cover the medical history, WHO functional class, physical examination, ECG, echocardiography at rest and during exercise, spiroergometry, quality of life, blood-gas analysis, lung function, 6-minute walking distance, oxygen saturation, blood pressure and heart rate, laboratory tests. An optional magnet resonance imaging at the beginning and after three months may also be conducted. At baseline, an optional genetic assessment will be performed; and at the beginning, after three and 15 weeks the expression levels of micro RNA and methylation of the DNA will be assessed. Medication will remain stable throughout the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consent form

• Men and women >18 years

• Symptomatic PH (WHO-FC II-IV) invasive diagnostis with right heart catheterization:

mPAP >25mmHg and a stable optimized treatment for at least 2 month

• Patients who are able to understand and agree to participate in the study

Exclusion Criteria:

• Pregnancy or breast feeding

• Variation in the medication during the last 2 months

• Patients with signs of right heart decompensation

• Major walking problems

• Unclear diagnosis

• No invasive clarification of the PH

• Acute illness, infections and fever

• Grave lung disease with FEV1 <50% or TLC <70% from target

• Further conclusion criteria are followed: acrive myokarditis, unstable angina pectoris, movement induced ventricular rhythmdisturbance, decompensation of the right hart insufficiency, meaningful heartvitien, hyperthrophic obstructive cardiomyopathie or a high grade reduced left ventricular pump function

• Acute psychosis or other conditions which appears a reduced understanding

• Patiets with metallic valvular or other metallic implants

• Incorporated ferromagnetic materials or for the MRI incompatibel activce medicinal products

• Claustrophobia

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• exercise and respiratory therapy
three weeks in-Hospital exercise Rehabilitation program with continuation at home (total 15 weeks).

Locations

Country	Name	City	State
Germany	Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute Walking distance	Walking distance in metres	change from baseline to final assessment after 3 months
Secondary	Peak oxygen consumption	Peak oxygen consumption during cardiopulmonary exercise testing	change from baseline to final assessment after 3 months
Secondary	Ventilatory equivalent, assessed during cardiopulmonary exercise testing at Peak exercise	Ventilatory equivalent during cardiopulmonary exercise testing	change from baseline to final assessment after 3 months
Secondary	Workload during cardiopulmonary exercise testing	Peak workload in Watts	change from baseline to final assessment after 3 months
Secondary	Epigenetic mechanisms; changes in micro RNA methylation/expression	changes in epigenetic mechanisms	change from baseline to final assessment after 3 months
Secondary	Echocardiography systolic pulmonary arterial pressure	systolic pulmonary arterial pressure	change from baseline to final assessment after 3 months
Secondary	Echocardiography right ventricular area	right ventricular area in cm^2	change from baseline to final assessment after 3 months
Secondary	Echocardiography right atrial area	right atrial area in cm^2	change from baseline to final assessment after 3 months
Secondary	Echocardiography tricuspid annular plane systolic excursion	tricuspid annular plane systolic excursion	change from baseline to final assessment after 3 months
Secondary	Echocardiography right ventricular pump function	right ventricular pump function qualitative	change from baseline to final assessment after 3 months
Secondary	World Health Organization functional class	functional class of patient's symptoms	change from baseline to final assessment after 3 months
Secondary	Laboratory NT-proBNP	NT-proBNP as marker of right heart insufficiency	change from baseline to final assessment after 3 months
Secondary	Quality of life physical Summation score; scores from 0-100 with higher scores indicating better outcome	short form health Survey 36 physical Summation score	change from baseline to final assessment after 3 months
Secondary	Quality of life mental Summation score; scores from 0-100 with higher scores indicating better outcome	short form health Survey 36 mental Summation score	change from baseline to final assessment after 3 months
Secondary	Blood gas Analysis Oxygen saturation	Oxygen Saturation at rest	change from baseline to final assessment after 3 months