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临床试验/NCT04761380
NCT04761380已完成不适用

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

Kindai University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
maximum tongue pressure

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

maximum tongue pressure

时间窗: 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.

次要结局

  • fat free mass index (FFMI)(1 day)
  • skeletal muscle mass(1 day)
  • height(1 day)
  • handgrip strength(1 day)
  • skeletal muscle mass (SMI)(1 day)
  • fat free mass(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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