Exercise and Respiratory Training as Supportive Treatments for Patients With Chronic Pulmonary Hypertension

Phase 3 Study of Physical Exercise and Respiratory Training as Supportive Treatments for Patients With Severe Chronic Pulmonary Hypertension

Background

-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.

Methods

-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.

Prospects

-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.

Study Overview

• Status: Completed
• Conditions: Chronic Pulmonary Hypertension
• Intervention / Treatment: Behavioral: Exercise and Respiratory Training

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with severe chronic PH who were stable and compensated under optimized medical therapy (such as endothelin antagonists, iloprost, sildenafil, calcium channel blockers, anticoagulants, diuretics, and supplemental oxygen) for at least 3 months before entering the study will be invited to participate.

Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.

Exclusion Criteria:

• Patients with recent syncope or skeletal or muscle abnormalities prohibiting participation in an exercise program won't be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise and Respiratory Training	Behavioral: Exercise and Respiratory Training; Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
distance walked in 6 minutes	baseline - 15 weeks afterwards
change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire	baseline - 15 weeks afterwards

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in WHO functional classification	baseline - 15 weeks afterwards
Borg scale assessed immediately after completion of the stress Doppler echocardiography	baseline - 15 weeks afterwards
parameters of echocardiography	baseline - 15 weeks afterwards
parameters of gas exchange	baseline - 15 weeks afterwards

Collaborators and Investigators

• Sponsor: Heidelberg University

Publications and helpful links

General Publications

• Nagel C, Prange F, Guth S, Herb J, Ehlken N, Fischer C, Reichenberger F, Rosenkranz S, Seyfarth HJ, Mayer E, Halank M, Grunig E. Exercise training improves exercise capacity and quality of life in patients with inoperable or residual chronic thromboembolic pulmonary hypertension. PLoS One. 2012;7(7):e41603. doi: 10.1371/journal.pone.0041603. Epub 2012 Jul 25.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 20, 2011

Study Record Updates

• Last Update Posted (Estimate): July 2, 2014
• Last Update Submitted That Met QC Criteria: July 1, 2014
• Last Verified: July 1, 2014

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: 364/2003