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临床试验/NCT05771506
NCT05771506已完成不适用

Determinants of Balance in Patients With Chronic Obstructive Pulmonary Disease

Biruni University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Forced vital capacity (FVC)

研究概览

简要总结

The primary aim of our study is to examine the relationship between balance and respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function in patients with Chronic Obstructive Pulmonary Disease (COPD). The secondary aim of our study is to compare respiratory function, respiratory and peripheral muscle strength, functional capacity, balance, and cognitive functions of COPD patients and healthy individuals. This study will examine and record the participant's sociodemographic information and medical records. Balance, respiratory function, respiratory and peripheral muscle strength, functional capacity, and cognitive function will be assessed. Since the patients are included in this study, no intervention will be made, no additional tests will be performed, or no changes will be made in the routine treatments of the patients during the study.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Being diagnosed with COPD in accordance with the GOLD criteria
  • Being between the ages of 40-65
  • To be able to speak, read, understand, and cooperate in Turkish
  • Being a volunteer to participate in the study

排除标准

  • Having a COPD exacerbation in the last 8 weeks and/or having an unstable clinical condition
  • Having a diagnosed vision, hearing, or neurological disease that may affect balance
  • Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
  • Resting saturation below 90% during exercise tests
  • Being on long-term oxygen therapy
  • Control Group Inclusion Criteria:
  • Being between the ages of 40-65
  • To be able to speak, read, understand, and cooperate in Turkish
  • Being a volunteer to participate in the study
  • Control Group Exclusion Criteria:
  • Having a diagnosed vision, hearing, or neurological disease that may affect balance
  • Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
  • Resting saturation below 90% during exercise tests

结局指标

主要结局

Forced vital capacity (FVC)

时间窗: 10-15 minutes

Maximal inspiratory pressure (MIP)

时间窗: 15-20 minutes

Quadriceps muscle strength

时间窗: 15-20 minutes

MoCA test

时间窗: 10-15 minutes

FEV1/FVC

时间窗: 10-15 minutes

6-minute walk test

时间窗: 15-20 minutes

Sensory integration test of balance: Composite score

时间窗: 20-30 minutes

Forced expiratory volume in 1 second (FEV1)

时间窗: 10-15 minutes

Peak expiratory flow (PEF)

时间窗: 10-15 minutes

Stability limits test: Overall score

时间窗: 15-20 minutes

Maximal expiratory pressure (MEP)

时间窗: 15-20 minutes

Postural stability test: Overall score

时间窗: 15-20 minutes

Forced expiratory flow 25-75% (FEF25-75)

时间窗: 10-15 minutes

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hikmet Ucgun

Assistant Professor

Biruni University

研究点 (1)

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