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

NCT04761380 | Completed

• 1 other identifier: 0414
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

dysphagia

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (6)

• handgrip strength

  1 day

• fat free mass index (FFMI)

  1 day

• skeletal muscle mass (SMI)

  1 day

• fat free mass

  1 day

• skeletal muscle mass

  1 day

Study Arms (2)

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

Interventions

balloon-based tongue pressure measurement device DIAGNOSTIC_TEST

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.

Also known as: Bioelectrical impedance analysis

age-matched control subjects subjects who did not have any pulmonary disease; stable COPD subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Clinical diagnosis of stable COPD.
• Age-matched control subjects who did not have any pulmonary disease.

You may not qualify if:

• Participants with metallic implants.
• History of stroke disease.
• History of neuromuscular disease.
• Participants who did not have their front teeth.

Sponsors & Collaborators

• Kindai University: lead

Study Sites (1)

Kindai University Faculty of Medicine

Ōsaka-sayama, Osaka, 5898511, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Deglutition Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: February 18, 2021
• Study Start: December 1, 2019
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)