Clinical trial NCT01398345: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Pulmonary Hypertension
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: distance walked in 6 minutes
timeFrame: baseline - 15 weeks afterwards
measure: change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire
timeFrame: baseline - 15 weeks afterwards
Secondary outcomes:
measure: changes in WHO functional classification
timeFrame: baseline - 15 weeks afterwards
measure: Borg scale assessed immediately after completion of the stress Doppler echocardiography
timeFrame: baseline - 15 weeks afterwards
measure: parameters of echocardiography
timeFrame: baseline - 15 weeks afterwards
measure: parameters of gas exchange
timeFrame: baseline - 15 weeks afterwards
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
Study officials:
References:
citation: 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.