Training Single Arm

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Other: exercise and respiratory therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Recruiting
    • Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise and respiratory therapy; Rehabilitation program for three weeks in-Hospital and continuation at home	Other: exercise and respiratory therapy; three weeks in-Hospital exercise Rehabilitation program with continuation at home (total 15 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute Walking distance	Walking distance in metres	change from baseline to final assessment after 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen consumption	Peak oxygen consumption during cardiopulmonary exercise testing	change from baseline to final assessment after 3 months
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
Workload during cardiopulmonary exercise testing	Peak workload in Watts	change from baseline to final assessment after 3 months
Epigenetic mechanisms; changes in micro RNA methylation/expression	changes in epigenetic mechanisms	change from baseline to final assessment after 3 months
Echocardiography systolic pulmonary arterial pressure	systolic pulmonary arterial pressure	change from baseline to final assessment after 3 months
Echocardiography right ventricular area	right ventricular area in cm^2	change from baseline to final assessment after 3 months
Echocardiography right atrial area	right atrial area in cm^2	change from baseline to final assessment after 3 months
Echocardiography tricuspid annular plane systolic excursion	tricuspid annular plane systolic excursion	change from baseline to final assessment after 3 months
Echocardiography right ventricular pump function	right ventricular pump function qualitative	change from baseline to final assessment after 3 months
World Health Organization functional class	functional class of patient's symptoms	change from baseline to final assessment after 3 months
Laboratory NT-proBNP	NT-proBNP as marker of right heart insufficiency	change from baseline to final assessment after 3 months
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
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
Blood gas Analysis Oxygen saturation	Oxygen Saturation at rest	change from baseline to final assessment after 3 months

Collaborators and Investigators

• Sponsor: Heidelberg University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2015
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Training single arm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No