Chronic Obstructive Pulmonary DiseaseNCT04761380
Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
An observational study of Chronic Obstructive Pulmonary Disease, run by Kindai University at 1 site in Japan.
Trial summary
Background: Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- balloon-based tongue pressure measurement device
- How many people
- 51 participants
- Where
- 1 siteJapan
- Study dates
- 1 Dec 2019to 10 May 2020
- How long will I take part?
- 1 Day
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: COPD subjects were chosen from a group of subjects who had visited the Department of Respiratory Medicine and Allergology at Kindai University Hospital from December 2019 to May 2020.
Who may be able to join
- Clinical diagnosis of stable COPD.
- Age-matched control subjects who did not have any pulmonary disease.
Who cannot join
- Participants with metallic implants.
- History of stroke disease.
- History of neuromuscular disease.
- Participants who did not have their front teeth.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects.
Read more
Methods:
This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- balloon-based tongue pressure measurement device
- Keywords
- dysphagia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balloon-based tongue pressure measurement deviceDiagnostic test
Also called Bioelectrical impedance analysis
The probe was inflated at a baseline pressure of 19.6 kilopascal (kPa). To measure MTP, the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP.
| Study group | Role | What they receive |
|---|---|---|
| stable COPD subjects | Not described Receives: Diagnostic Test: balloon-based tongue pressure measurement device | |
| age-matched control subjects subjects who did not have any pulmonary disease | Not described Receives: Diagnostic Test: balloon-based tongue pressure measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tongue pressure
To measure maximum tongue pressure (MTP), the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP.
Measured: 1 day
Secondary outcomes (6)
handgrip strength
Handgrip strength was measured three times for the right hand using a grip strength dynamometer and mean values were used.
Measured: 1 day
fat free mass index (FFMI)
FFMI (kg/m^2) was calculated by fat free mass／height^2(m^2).
Measured: 1 day
skeletal muscle mass (SMI)
SMI (kg/m^2) was calculated by skeletal muscle mass ／height^2(m^2).
Measured: 1 day
fat free mass
Fat free mass was measured using the medical body composition analyzer. It is designed for measurements in the supine position, using four pairs of electrodes (eight electrodes in total), positioned on each hand and foot21. Supine measurements were taken after lying down for 10 minutes. Alcohol was prohibited for 24h prior to the impedance measurements.
Measured: 1 day
skeletal muscle mass
Skeletal muscle mass was measured using the medical body composition analyzer. It is designed for measurements in the supine position, using four pairs of electrodes (eight electrodes in total), positioned on each hand and foot21. Supine measurements were taken after lying down for 10 minutes. Alcohol was prohibited for 24h prior to the impedance measurements.
Measured: 1 day
height
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Dec 2019
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761380
- Sponsor's protocol ID
- 0414
- Status last verified
- Feb 2021
- First submitted
- 9 Oct 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
- ClinicalTrials.gov ID
- NCT04761380
- Acronym / sponsor ID
- 0414
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 18 Feb 2021 (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:
Dysphagia is frequently observed in subjects with chronic obstructive pulmonary disease (COPD). But tongue strength has not been investigated yet in COPD subjects. The investigators hypothesized that tongue strength is weaker in COPD subjects compared to normal subjects.
Methods:
This was a single-centre, observational, and cross-sectional study. Twenty-seven subjects with COPD and twenty-four age-matched control subjects were enrolled in this study. Isometric tongue strength was measured using a device fitted with a disposable oral balloon probe. The investigators also evaluated handgrip strength, gait speed, and appendicular skeletal muscle mass (ASM) to define participants as having sarcopenia. ASM, fat free mass index (FFMI), and skeletal muscle mass index (SMI) were measured by bioelectrical impedance analysis. Gait speed was measured using the 6-meter walking test. The eating assessment test-10 (EAT-10) was used to diagnose dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable COPD subjects | – | Diagnostic Test: balloon-based tongue pressure measurement device |
| age-matched control subjects subjects who did not have any pulmonary disease | – | Diagnostic Test: balloon-based tongue pressure measurement device |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- COPD subjects were chosen from a group of subjects who had visited the Department of Respiratory Medicine and Allergology at Kindai University Hospital from December 2019 to May 2020.
Key inclusion criteria (2 listed)
- Clinical diagnosis of stable COPD.
- Age-matched control subjects who did not have any pulmonary disease.
Key exclusion criteria (4 listed)
- Participants with metallic implants.
- History of stroke disease.
- History of neuromuscular disease.
- Participants who did not have their front teeth.
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 |
|---|---|---|
| balloon-based tongue pressure measurement deviceAlso: Bioelectrical impedance analysisThe probe was inflated at a baseline pressure of 19.6 kilopascal (kPa). To measure MTP, the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP. | Diagnostic test | age-matched control subjects subjects who did not have any pulmonary disease, stable COPD subjects |
Primary outcome
maximum tongue pressure
Time frame: 1 day
To measure maximum tongue pressure (MTP), the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP.
6 secondary outcomes
handgrip strength
Time frame: 1 day
fat free mass index (FFMI)
Time frame: 1 day
skeletal muscle mass (SMI)
Time frame: 1 day
fat free mass
Time frame: 1 day
skeletal muscle mass
Time frame: 1 day
height
Time frame: 1 day
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 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Obstructive Pulmonary Disease, run by Kindai University at 1 site in Japan.
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 2 inclusion and 4 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 Feb 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 Japan. 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?
maximum tongue pressure (time frame: 1 day). 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 Feb 2021.