Back to results

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

Primary Purpose

Chronic Pulmonary Hypertension

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Exercise and Respiratory Training

About this trial

This is an interventional treatment trial for Chronic Pulmonary Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Thoraxklinik Heidelberg

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Exercise and Respiratory Training

Arm Description

Outcomes

Primary Outcome Measures

distance walked in 6 minutes

change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire

Secondary Outcome Measures

changes in WHO functional classification

Borg scale assessed immediately after completion of the stress Doppler echocardiography

parameters of echocardiography

parameters of gas exchange

Full Information

NCT ID

NCT01398345

First Posted

July 19, 2011

Last Updated

July 1, 2014

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT01398345

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

December 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pulmonary Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Exercise and Respiratory Training

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Exercise and Respiratory Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

distance walked in 6 minutes

Time Frame