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CompletedNCT02054728Updated Oct 30, 2018

Inspiratory Muscle Training During Right-heart Catheterization

An interventional study of RHC and IMT in Right-heart Hemodynamics, Respiratory Muscle Training and Inspiratory Resistance, sponsored by Wissenschaftliches Institut Bethanien e.V. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by Wissenschaftliches Institut Bethanien e.V · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Right-heart Hemodynamics
  • Respiratory Muscle Training
  • Inspiratory Resistance

Keywords

  • right-heart catheterization
  • respiratory muscle training
  • inspiratory resistance
  • hemodynamics
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 20 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Wissenschaftliches Institut Bethanien e.V is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    RHC and IMT

    Other: RHC and IMT

Interventions

  • OtherRHC 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.

06

What researchers measure

Primary outcomes

  1. Change in Pulmonary arterial pressure

    Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.

    Time frame: During RHC with and without parallel IMT

Secondary outcomes

  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

07

Study locations

1 site
  • Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
    Solingen, NRW 42699, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02054728
Lead sponsor
Wissenschaftliches Institut Bethanien e.V
Responsible party
Sponsor
First posted
Feb 4, 2014
Start date
Oct 16, 2012
Primary completion
Dec 1, 2014
Completion
Dec 1, 2014
Last update
Oct 30, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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