Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects

• Sponsor: Kindai University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04761380
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 9.6

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Diagnostic Test: balloon-based tongue pressure measurement device

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Decreased Tongue Strength is Related to Skeletal Muscle Mass in COPD Subjects
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: May 10, 2020
• Actual Study Completion Date: May 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
stable COPD subjects	Diagnostic Test: balloon-based tongue pressure measurement device; 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.; Other Names: Bioelectrical impedance analysis
age-matched control subjects subjects who did not have any pulmonary disease	Diagnostic Test: balloon-based tongue pressure measurement device; 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.; Other Names: Bioelectrical impedance analysis

Outcome Measures

Primary Outcome Measures

1. maximum tongue pressure [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.

Secondary Outcome Measures

1. handgrip strength [1 day]

   Handgrip strength was measured three times for the right hand using a grip strength dynamometer and mean values were used.

2. fat free mass index (FFMI) [1 day]

   FFMI (kg/m^2) was calculated by fat free mass／height^2(m^2).

3. skeletal muscle mass (SMI) [1 day]

   SMI (kg/m^2) was calculated by skeletal muscle mass ／height^2(m^2).

4. fat free mass [1 day]

   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.

5. skeletal muscle mass [1 day]

   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.

6. height [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Clinical diagnosis of stable COPD.

• Age-matched control subjects who did not have any pulmonary disease.

Exclusion Criteria:

• Participants with metallic implants.

• History of stroke disease.

• History of neuromuscular disease.

• Participants who did not have their front teeth.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kindai University Faculty of Medicine	Ōsaka-sayama	Osaka	Japan	5898511

Sponsors and Collaborators

• Kindai University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kindai University
• ClinicalTrials.gov Identifier: NCT04761380
• Other Study ID Numbers: 0414
• First Posted: Feb 18, 2021
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kindai University: dysphagia
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Feb 18, 2021