Respiratory Muscle Fatigue at Different Breathing Modes
Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing
1 other identifier
interventional
12
1 country
1
Brief Summary
The study aims at investigating if time to respiratory muscle fatigue and metabolism are influenced by the pressure wave form mode applied during resistive breathing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Oct 2021
Typical duration for not_applicable healthy
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 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
May 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 26, 2022
May 1, 2022
1.2 years
April 21, 2022
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Time to task failure (Tlim)
The time (s) from the subject starts to breathe under the experimental condition, and until task failure will be measured. Task failure is defied by either subject intolerance to continue or by lacking ability of the subject to maintain the target pressure and/or timing. From a previous publication (Bellemare and Grassino, JAP, 1982), it is estimated that subjects will reach Tlim between 30min to 1 hour. If breathing is continued after 1 hour, task failure will not happen as breathing can be continued indefinitely.
Up to two months between the two different breathing trials (randomized order)
Secondary Outcomes (8)
Respiratory muscle pressures
Up to two months between the two different breathing trials (randomized order)
Tidal volume
Up to two months between the two different breathing trials (randomized order)
Respiratory work
Up to two months between the two different breathing trials (randomized order)
Ratings of perceived exertion
Up to two months between the two different breathing trials (randomized order)
Metabolism
Up to two months between the two different breathing trials (randomized order)
- +3 more secondary outcomes
Interventions
difference in time to failure from the two breathing modes
Eligibility Criteria
You may qualify if:
- Healthy men or women
- Age ≥18 and ≤60 years
- BMI ≥ 20 and ≤30
You may not qualify if:
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous and present neurologic (e.g. ataxia), musculoskeletal (e.g. muscular dystrophy) or mental illnesses (e.g. schizophrenia)
- History of mechanical ventilation, COVID-19 with respiratory complications, lung cancer
- Part of lung resected
- Presence of dyspepsia/heart-burn/abdominal pain
- Presence of esophageal varices
- Presence of liver disease
- Presence of esophageal hernia
- Pregnancy
- Failure to comply with transcranial magnetic stimulation adult safety screen
- History of epilepsy, metal implants in head or jaw
- Acute or chronic lung diseases, e.g. asthma, COPD, bronchitis etc.
- Lack of ability to cooperate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mathias Krogh Poulsen
Aalborg, Danmark, 9220, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Associate Professor
Study Record Dates
First Submitted
April 21, 2022
First Posted
May 26, 2022
Study Start
October 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share