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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension|
- Improvement of peak O2 uptake (VO2peak) under stress [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]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.
- Changes in hemodynamics at rest and during exercise [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: respiratory and exercise therapy
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
|No Intervention: respiratory and exercise therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394367
|Contact: Ekkehard Grünig, Professor||+49 6221 email@example.com|
|Contact: Nicola Ehlken, BSc||+49 6221 firstname.lastname@example.org|
|Center for pulmonary Hypertension, Thoraxclinic Heidelberg||Recruiting|
|Heidelberg, Germany, 69126|
|Contact: Ekkehard Grünig, Professor +49 6221 396 8053 email@example.com|
|Contact: Nicola Ehlken, BSc +49 6221 396 8076 firstname.lastname@example.org|
|Principal Investigator: Ekkehard Grünig, Professor|
|Study Director:||Ekkehard Grünig, Professor||Center for pulmonary hypertension, Thoraxclinic Heidelberg|