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Completed

NCT Number: NCT01394367

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, 69126, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory and exercise therapy

Other

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

Primary outcomes

  1. Improvement of peak O2 uptake (VO2peak) under stress

    Time frame: 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 outcomes

  1. Changes in hemodynamics at rest and during exercise

    Time frame: up to 15 weeks

    • 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

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2011
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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