Training Single Arm

NCT04224025 | Unknown

• 1 other identifier: Training single arm
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 6-minute Walking distance

  Walking distance in metres

  change from baseline to final assessment after 3 months

Secondary Outcomes (14)

• Peak oxygen consumption

  change from baseline to final assessment after 3 months

• Ventilatory equivalent, assessed during cardiopulmonary exercise testing at Peak exercise

  change from baseline to final assessment after 3 months

• Workload during cardiopulmonary exercise testing

  change from baseline to final assessment after 3 months

• Epigenetic mechanisms; changes in micro RNA methylation/expression

  change from baseline to final assessment after 3 months

• Echocardiography systolic pulmonary arterial pressure

  change from baseline to final assessment after 3 months

Study Arms (1)

exercise and respiratory therapy

EXPERIMENTAL

Rehabilitation program for three weeks in-Hospital and continuation at home

Other: exercise and respiratory therapy

Interventions

exercise and respiratory therapy OTHER

three weeks in-Hospital exercise Rehabilitation program with continuation at home (total 15 weeks).

exercise and respiratory therapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital

Heidelberg, 69126, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Exercise; Respiratory Therapy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig, Head of centre for pulmonary hypertension

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 13, 2020
• Study Start: November 3, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)