Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Other: respiratory and exercise therapy

• Registration Number: NCT01394367
• Lead Sponsor: Heidelberg University

Brief Summary

Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-19
• Last Update Posted: 2019-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Consent form
• men and women> 18 years <75 years
• invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

Exclusion Criteria

• Pregnancy or lactation
• Change in medication during the last 2 months
• Patients with signs of right heart decompensation
• severe walking disturbance
• uncertain diagnoses
• No previous invasively confirmation of PH
• acute diseases, infections, fever
• Serious lung disease with FEV1 <50% or TLC <70% of target
• Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory and exercise therapy	respiratory and exercise therapy	Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.

Primary Outcome Measures

Name	Time	Method
Improvement of peak O2 uptake (VO2peak) under stress	up to 15 weeks	Three-week inpatient rehabilitation, continuation of the training program for another 12 weeks at home (exercise group), patients in the control group continued their usual activities. After 15 weeks, training is also offered to patients in the control group.

Secondary Outcome Measures

Name	Time	Method
Changes in hemodynamics at rest and during exercise	up to 15 weeks	1. Changes in hemodynamics at rest and during exercise after three weeks and 15 weeks: RAP, RVP, sPAP, DPAP, mPAP, PCWP, cardiac output, PVR, CI, SvO2; 2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2); 3. Improved condition(NYHA class, Borg scale); 4. Changes in MRI and echocardiographic parameters of right and left ventricle: size and pump function.; 5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

Trial Locations

Locations (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg; 🇩🇪 Heidelberg, Germany