Back to resultsInfluence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
respiratory and exercise therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Hypertension focused on measuring respiratory therapy, exercise therapy, oxygen uptake, quality of life, right ventricular function, severe pulmonary hypertension
Eligibility Criteria
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
Sites / Locations
- Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Respiratory and exercise therapy
respiratory and exercise therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01394367
Brief Title
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
respiratory therapy, exercise therapy, oxygen uptake, quality of life, right ventricular function, severe pulmonary hypertension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiratory and exercise therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
respiratory and exercise therapy
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
respiratory and exercise therapy
Intervention Description
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
Primary Outcome Measure Information:
Title
Improvement of peak O2 uptake (VO2peak) under stress
Description
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.
Time Frame
up to 15 weeks
Secondary Outcome Measure Information:
Title
Changes in hemodynamics at rest and during exercise
Description
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
Time Frame
up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekkehard Grünig, Professor
Organizational Affiliation
Center for pulmonary hypertension, Thoraxclinic Heidelberg
Official's Role
Study Director
Facility Information:
Facility Name
Center for pulmonary Hypertension, Thoraxclinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
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