Inspiratory Muscle Training During Right-heart Catheterization
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 30, 2018
October 1, 2018
2.1 years
December 20, 2012
October 26, 2018
Conditions
Keywords
Outcome Measures
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.
During RHC with and without parallel IMT
Secondary Outcomes (5)
Change in Pulmonary Capillary Wedge Pressure
During RHC with and without parallel IMT
Change in Cardiac output
During RHC with and without parallel IMT
Change in Cardiac index
During RHC with and without parallel IMT
Change in Stroke volume index
During RHC with and without parallel IMT
Change in Stroke volume
During RHC with and without parallel IMT
Study Arms (1)
RHC and IMT
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Indication for right-heart catheterization
- Informed Consent provided
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Solingen, North Rhine-Westphalia, 42699, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
February 4, 2014
Study Start
October 16, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
October 30, 2018
Record last verified: 2018-10