Chronic Respiratory DiseaseNCT03880630
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
A study testing Inspiratory muscle training in people with Chronic Respiratory Disease and Inspiratory Muscle Training, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background \& Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Oct 2020to 31 Dec 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
- 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 & Graduate Institute of Physical Therapy, College of Medicine, NTU
Taipei, 100
About this study
Background \& Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive.
The purposes of the study are to investigate in patients with chronic respiratory disease: (Year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various IMT loading using group-based trajectory modeling (GBTM); and (Year 2) effectiveness of individualized IMT program (based on results of Year 1) on clinical outcomes. Methods: (Year 1) Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Surface electromyography (EMG) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. Other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. Inspiratory muscle activation will be used for GBTM analysis. Patient will then be trained with individualized IMT program based on the GBTM analysis input form results of Year 1.
- Conditions
- Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle, Surface Electromyography
- Being tested
- Inspiratory muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Patient will then be trained with individualized IMT program based on the results of 3 inspiratory loading tests.
| Study group | Role | What they receive |
|---|---|---|
| Chronic respiratory disease | Experimental | Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study Receives: Other: Inspiratory muscle training |
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 inspiratory loading tests 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 five minute after the completion of the loaded inspiratory muscle test condition
Pulmonary function
Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
Measured: About five minutes to complete
Maximal inspiratory pressure test
Maximal inspiratory pressure
Measured: About three minutes to complete
Functional exercise capacity using the six-minute walk test
The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity
Measured: The six-minute walk test needs six minute to complete the test
Heart rate
Heart rate is measured at rest, during six-minute walk test
Measured: The six-minute walk test needs six minute to complete the test
Blood pressure
systolic and diastolic pressure are measured at rest, after six-minute walk test
Measured: Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure
Perceived dyspnea
Rating of perceived dyspnea is measured by using Borg scale at rest, during six-minute walk test, inspiratory loading tests. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).
Measured: It takes less than one minute to evaluate perceived dyspnea
Oxygen saturation
Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests
Measured: The six-minute walk test needs six minute to complete the test; through the completion of the inspiratory loading tests condition; it would take about 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start6 Oct 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT03880630
- Sponsor's protocol ID
- 201812172RIND
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2019
- Last updated
- 18 Mar 2021
- 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 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT03880630
- Acronym / sponsor ID
- 201812172RIND
- Conditions
- Chronic Respiratory Disease, Inspiratory Muscle Training, Sternocleidomastoid Muscle, Surface Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Mar 2019 (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.
Background \& Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive.
The purposes of the study are to investigate in patients with chronic respiratory disease: (Year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various IMT loading using group-based trajectory modeling (GBTM); and (Year 2) effectiveness of individualized IMT program (based on results of Year 1) on clinical outcomes. Methods: (Year 1) Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Surface electromyography (EMG) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. Other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. Inspiratory muscle activation will be used for GBTM analysis. Patient will then be trained with individualized IMT program based on the GBTM analysis input form results of Year 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic respiratory disease | Experimental | Other: Inspiratory muscle trainingPatients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 20 years old
- has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
- can cooperate with the measurements of this study
Key exclusion criteria (6 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
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 |
|---|---|---|
| Inspiratory muscle trainingPatients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Patient will then be trained with individualized IMT program based on the results of 3 inspiratory loading tests. | Other | Chronic respiratory disease |
Primary outcome
Diaphragm and Sternocleidomastoid muscle activation
Time frame: through the completion of the inspiratory loading tests 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 five 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
Pulmonary function
Time frame: About five minutes to complete
Forced expiratory volume in one second, forced vital capacity, residual volume, total lung capacity
Maximal inspiratory pressure test
Time frame: About three minutes to complete
Maximal inspiratory pressure
Functional exercise capacity using the six-minute walk test
Time frame: The six-minute walk test needs six minute to complete the test
The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity
Heart rate
Time frame: The six-minute walk test needs six minute to complete the test
Heart rate is measured at rest, during six-minute walk test
Blood pressure
Time frame: Before and immediately after the six-minute walk test;it takes less than one minute to measure blood pressure
systolic and diastolic pressure are measured at rest, after six-minute walk test
Perceived dyspnea
Time frame: It takes less than one minute to evaluate perceived dyspnea
Rating of perceived dyspnea is measured by using Borg scale at rest, during six-minute walk test, inspiratory loading tests. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).
Oxygen saturation
Time frame: The six-minute walk test needs six minute to complete the test; through the completion of the inspiratory loading tests condition; it would take about 3 minutes
Oxygen saturation is continuously monitored by pulse oximetry throughout six-minute walk test, inspiratory loading tests
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 18 Mar 2021.
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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?
A study testing Inspiratory muscle training in people with Chronic Respiratory Disease and Inspiratory Muscle Training, 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 6 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 18 Mar 2021. 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 inspiratory loading tests condition; it would take about 3 minutes). The study lists 9 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 18 Mar 2021.