Effect of Exercise and Respiratory Therapy on Right Ventricular Function in Severe Pulmonary Hypertension

NCT04224012 | Unknown

• 1 other identifier: TRAIN-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pulmonary hypertension (PH) is associated with impaired exercise capacity, quality of life and right ventricular function.The disease is characterized by an increase of pulmonary vascular resistance and pulmonary arterial pressure, leading to right heart insufficiency. In later stages of the disease, the right heart is not able to further increase right ventricular contractility (cardiac index) during exercise. Within the last decade, new disease-targeted medical therapies have been approved for treatment of pulmonary arterial hypertension (PAH). Sequential and upfront combinations of these agents have shown to further improve symptoms, 6-minute walking distance (6-MWD) and hemodynamics in PAH patients. Previous training studies have suggested that exercise training as add-on to medical treatment is highly effective improving exercise capacity, quality of life and symptoms. Prospective studies with a 24±12 months follow-up period suggested that exercise training may also improve the rate of clinical worsening events as the need for hospitalization, additional PH-medication, lung-transplantation and death. There is also first data that exercise training may have a positive impact on the right ventricular function. This randomised controlled study aims to assess whether exercise training

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Cardiac index during exercise, right heart catheter

  measured by right heart catheterisation; Training vs. control group

  Change form baseline to final assessment after 15 weeks

Secondary Outcomes (19)

• Cardiac index at rest, right heart catheter

  Change form baseline to final assessment after 15 weeks

• Pulmonary vascular resistance at rest, right heart catheter

  Change form baseline to final assessment after 15 weeks

• 6-minute Walking distance

  Change form baseline to final assessment after 15 weeks

• Peak oxygen consumption, cardiopulmonary exercise testing

  Change form baseline to final assessment after 15 weeks

• Peak Workload in Watts, achieved during cardiopulmonary exercise testing

  Change form baseline to final assessment after 15 weeks

Study Arms (2)

Conventional therapy group (control group)

NO INTERVENTION

patients of the control Group receive usual care

Interventional group (training group)

EXPERIMENTAL

Specialized exercise and respiratory therapy for patients with pulmonary hypertension

Other: Exercise and respiratory therapy

Interventions

Exercise and respiratory therapy OTHER

Three weeks in-Hospital Rehabilitation program with continuation of exercise Training at home

Interventional group (training group)

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
• Ptients 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 venr´tricular rhythmdisturbance, decompensation of the right hart insufficiency, meaningful heartvitien, hyperthrophic obstructive cardiomyopathie or a high grade reduced left ventricular pumpu function

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• 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: August 1, 2015
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

DE (1)