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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394367
• Other study ID #: S-472/2009
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: May 2015

Study information

• Verified date: December 2019
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training

Locations

Country	Name	City	State
Germany	Center for pulmonary Hypertension, Thoraxclinic Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of peak O2 uptake (VO2peak) under stress	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.	up to 15 weeks
Secondary	Changes in hemodynamics at rest and during exercise	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; Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2); Improved condition(NYHA class, Borg scale); Changes in MRI and echocardiographic parameters of right and left ventricle: size and pump function.; Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins	up to 15 weeks