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

NCT ID: NCT01394367

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Keywords

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respiratory therapy exercise therapy oxygen uptake quality of life right ventricular function severe pulmonary hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

respiratory and exercise therapy

Intervention Type OTHER

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

respiratory and exercise therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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respiratory and exercise therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ekkehard Grünig, Professor

Role: STUDY_DIRECTOR

Center for pulmonary hypertension, Thoraxclinic Heidelberg

Locations

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Center for pulmonary Hypertension, Thoraxclinic Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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S-472/2009

Identifier Type: -

Identifier Source: org_study_id