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Inspiratory Muscle Training During Right-heart Catheterization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054728
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Brief Summary:
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.

Condition or disease Intervention/treatment Phase
Right-heart Hemodynamics Respiratory Muscle Training Inspiratory Resistance Other: RHC and IMT Not Applicable

Detailed Description:

During the last years, respiratory muscle training (RMT) in patients with impaired respiratory muscle function, e.g. in chronic obstructive pulmonary disease (COPD), is increasingly applied. RMT can be done by applying increased respiratory effort for several minutes via an apparatus providing an inspiratory stenosis. Threshold IMT® (Philips Respironics) for example is such a training device, which is in the market for several years now and which has been used to conduct studies applying RMT. For example, it has been shown that training with the Threshold IMT® in patients with COPD increases inspiratory muscle strength, endurance and functional capacity and ameliorates dyspnea and quality of life. Furthermore, patients suffering from cardiac illness can also be affected by respiratory muscle impairment, which can add to their cardiogenic dyspnea. RMT can help improve dyspnea and physical exercise capacity in those patients as well.

To date, no studies have been performed addressing acute hemodynamic effects of inspiratory muscle training. However, this is of special interest: COPD as well as heart failure patients show an increased prevalence of pulmonary hypertension.

In case of suspected pulmonary hypertension, patients usually are subjected to right-heart catheterization (RHC) to arrive at a definitive diagnosis and assess severity and etiology of potentially present pulmonary hypertension. RHC is also a sensitive method to exclude an intracardial shunt in COPD patients.

In this study, patients who are routinely subjected to RHC for the above mentioned reasons will be instructed to do RMT using the Threshold IMT® during RHC. Two days in advance they will begin a guided training to get familiar with the Threshold IMT®. The device's inspiratory resistance can be set between 9 and 41 cm H2O. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand.

During the RHC procedure the patients will again conduct RMT as instructed while the suspected hemodynamic effects will be documented.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Inspiratory Muscle Training During Right-heart Catheterization
Actual Study Start Date : October 16, 2012
Actual Primary Completion Date : December 1, 2014
Actual Study Completion Date : December 1, 2014

Arm Intervention/treatment
Experimental: RHC and IMT Other: RHC and IMT

Eligible patients subjected to RHC will be instructed on how to do RMT using the Threshold IMT® two days in advance. RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min).

The actual intervention consists of inspiratory muscle training (IMT) during right-heart catheterization for at least 2 min or as long as is necessary to measure all specified parameters.





Primary Outcome Measures :
  1. Change in Pulmonary arterial pressure [ Time Frame: During RHC with and without parallel IMT ]
    Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.


Secondary Outcome Measures :
  1. Change in Pulmonary Capillary Wedge Pressure [ Time Frame: During RHC with and without parallel IMT ]
  2. Change in Cardiac output [ Time Frame: During RHC with and without parallel IMT ]
  3. Change in Cardiac index [ Time Frame: During RHC with and without parallel IMT ]
  4. Change in Stroke volume index [ Time Frame: During RHC with and without parallel IMT ]
  5. Change in Stroke volume [ Time Frame: During RHC with and without parallel IMT ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Indication for right-heart catheterization
  • Informed Consent provided

Exclusion Criteria:

  • Age < 18 years
  • Inability or contraindication to undergo right-heart catheterization
  • Inability or contraindication to undergo respiratory muscle training as required per protocol
  • Pregnancy, lactation
  • Any medical, psychological or other condition restricting the patient's ability to provide informed consent
  • Participation in another clinical trial

Information from the National Library of Medicine

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): NCT02054728


Locations
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Germany
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Solingen, NRW, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V

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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT02054728    
Other Study ID Numbers: WI_IMT_RHK_82/2012
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Keywords provided by Wissenschaftliches Institut Bethanien e.V:
right-heart catheterization
respiratory muscle training
inspiratory resistance
hemodynamics
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes