Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT01394367|
Recruitment Status : Unknown
Verified July 2014 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was: Recruiting
First Posted : July 14, 2011
Last Update Posted : July 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Other: respiratory and exercise therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||June 2016|
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|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394367
|Contact: Ekkehard Grünig, Professor||+49 6221 firstname.lastname@example.org|
|Contact: Nicola Ehlken, BSc||+49 6221 email@example.com|
|Center for pulmonary Hypertension, Thoraxclinic Heidelberg||Recruiting|
|Heidelberg, Germany, 69126|
|Contact: Ekkehard Grünig, Professor +49 6221 396 8053 firstname.lastname@example.org|
|Contact: Nicola Ehlken, BSc +49 6221 396 8076 email@example.com|
|Principal Investigator: Ekkehard Grünig, Professor|
|Study Director:||Ekkehard Grünig, Professor||Center for pulmonary hypertension, Thoraxclinic Heidelberg|