Accessory MuscleNCT03729986
Activation Patterns of Respiratory Muscles to Loaded Inspiratory Muscle Tests in Healthy Adults Under Different Posture
An observational study of Accessory Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accessory Muscle
- What is being tested?
- Loaded inspiratory muscle test
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 28 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults that are willing to cooperate the measurement of this study.
Who may be able to join
- age > 20 years old
- without exercise habit (any exercise that less than 3 days/week)
- can cooperate with the measurements of this study
Who cannot join
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- participated in inspiratory muscle training program in the previous three months
- any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy of National Taiwan University
Taipei, Zhongzheng Dist, 100
About this study
Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.
Read the detailed description
Inspiratory muscle training usually performed in the upright sitting position. In healthy individuals, sternocleidomastoid (SCM) is rarely recruited during tidal breathing, but previous studies have demonstrated SCM activation during loaded inspiratory muscle tests in upright sitting position. Whether minimizing SCM activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.
- Conditions
- Accessory Muscle
- Being tested
- Loaded inspiratory muscle test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded inspiratory muscle testOther
Loaded inspiratory muscle tests will be set at 30% of maximal inspiratory pressure in sitting and supine positions. The orders of the two loaded test conditions will be conducted in random order with at least 20 minute separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy subjects without exercise habit that can cooperate with the measurements of this study, loaded inspiratory muscle test. Receives: Other: Loaded inspiratory muscle test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm and Sternocleidomastoid muscle activation
Root mean square values during different conditions
Measured: Through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
The mean median frequency of diaphragm and sternocleidomastoid muscle
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Measured: In one minute after the completion of the loaded inspiratory muscle test condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Nov 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accessory MuscleStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, Phd, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729986
- Sponsor's protocol ID
- 201807021RINA
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation Patterns of Respiratory Muscles to Loaded Inspiratory Muscle Tests in Healthy Adults Under Different Posture
- ClinicalTrials.gov ID
- NCT03729986
- Acronym / sponsor ID
- 201807021RINA
- Conditions
- Accessory Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.
Detailed description
Inspiratory muscle training usually performed in the upright sitting position. In healthy individuals, sternocleidomastoid (SCM) is rarely recruited during tidal breathing, but previous studies have demonstrated SCM activation during loaded inspiratory muscle tests in upright sitting position. Whether minimizing SCM activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: Loaded inspiratory muscle testHealthy subjects without exercise habit that can cooperate with the measurements of this study, loaded inspiratory muscle test. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults that are willing to cooperate the measurement of this study.
Key inclusion criteria (3 listed)
- age > 20 years old
- without exercise habit (any exercise that less than 3 days/week)
- can cooperate with the measurements of this study
Key exclusion criteria (5 listed)
- any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
- angina, acute myocardial infarction in the previous one month
- pregnancy
- participated in inspiratory muscle training program in the previous three months
- any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) < 24, that will disturb the communication and cooperation of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loaded inspiratory muscle testLoaded inspiratory muscle tests will be set at 30% of maximal inspiratory pressure in sitting and supine positions. The orders of the two loaded test conditions will be conducted in random order with at least 20 minute separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. | Other | Healthy adults |
Primary outcome
Diaphragm and Sternocleidomastoid muscle activation
Time frame: Through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
Root mean square values during different conditions
The mean median frequency of diaphragm and sternocleidomastoid muscle
Time frame: In one minute after the completion of the loaded inspiratory muscle test condition
The power spectrum is divided into two equal areas of the frequency value by median frequency to exam muscle fatigability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Ying Wang, Phd study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accessory Muscle, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm and Sternocleidomastoid muscle activation (time frame: Through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.