Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Heidelberg University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Improvement of peak O2 uptake (VO2peak) under stress
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: respiratory and exercise therapy (Other)
respiratory and exercise therapy
Outcomes
Primary Outcomes
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
- Changes in hemodynamics at rest and during exercise(up to 15 weeks)
Investigators
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University