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Completed

NCT Number: NCT04761380

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kindai University Faculty of Medicine

Ōsaka-sayama, Osaka, 5898511, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bioelectrical impedance analysis

Primary outcomes

  1. 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.

Secondary outcomes

  1. handgrip strength

    Time frame: 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)

    Time frame: 1 day

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

  3. skeletal muscle mass (SMI)

    Time frame: 1 day

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

  4. fat free mass

    Time frame: 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

    Time frame: 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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Kindai University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2021
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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