跳至主要内容
临床试验/NCT07249567
NCT07249567招募中不适用

Comparison of Respiratory and Peripheral Muscle Strength, Exercise Capacity, and Muscle Oxygenation in Individuals With COPD and PRISM

Karabuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Upper extremity exercise capacity

研究概览

简要总结

COPD is a preventable and treatable lung disease characterized by persistent and progressive airflow limitation. PRISm, on the other hand, is a spirometry pattern that does not meet COPD diagnostic criteria despite symptoms and functional impairments, but requires maintenance. PRISm can predispose to the development of COPD and exacerbations, and can reduce exercise capacity by reducing respiratory function and oxygen consumption. There are no studies in the literature comparing respiratory muscle strength, peripheral muscle strength, and oxygenation in PRISm, COPD, and healthy individuals. Therefore, this study aimed to evaluate these parameters and compare them with healthy individuals.

详细描述

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable multisystem lung disease characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to airway abnormalities, causing persistent and often progressive airflow limitation. PRISm is defined as a spirometry pattern that is not always a stable phenotype but should be considered "sick" because symptoms and/or functional and/or structural abnormalities are present and therefore require care and treatment. Recently, PRISm has been identified as a subtype more prone to developing COPD or experiencing acute exacerbations. In addition to affecting the respiratory muscles, PRISm's effects on respiratory function lead to decreased body oxygen consumption and increased dyspnea. PRISm can also lead to decreased exercise capacity due to the respiratory problems and dyspnea it causes. Although there are not enough studies in the literature investigating exercise capacity and lung functions on behalf of PRISm, no previous study comparing respiratory muscle strength, peripheral muscle strength and oxygenation in PRISm, COPD and healthy individuals has been found.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •For the COPD group:
  • •Being >40 years old,
  • •Being diagnosed with COPD,
  • •Being clinically stable,
  • •Volunteering to participate in the study.
  • •For the PRISm group:
  • •Being >40 years old,
  • •Being diagnosed with PRISm,
  • •Volunteering to participate in the study.
  • •For the healthy control group:
  • •Being >40 years old,
  • •Volunteering to participate in the study.

排除标准

  • •For the COPD group:
  • •Having severe orthopedic, neurological, or cardiac diseases,
  • •Being in a COPD exacerbation,
  • •Having a comorbid lung disease,
  • •Being on clinically unstable medication,
  • •Voluntarily not participating in the study.
  • •For the PRISm group:
  • •Being diagnosed with COPD,
  • •Having severe orthopedic, neurological, or cardiac diseases,
  • •Having a comorbid lung disease,
  • •Voluntarily not participating in the study.
  • •For the healthy control group:
  • •Having a known chronic disease,
  • •Voluntarily not participating in the study.

结局指标

主要结局

Upper extremity exercise capacity

时间窗: Baseline

Upper extremity exercise capacity will be evaluated with the six-minute pegboard and ring test (6-PBRT).

Lower extremity exercise capacity

时间窗: Baseline

Lower extremity exercise capacity will be evaluated with six- minute walking test.

Peripheral muscle strength

时间窗: Baseline

Peripheral muscle strength will be evaluated with a dynamometer.

Muscle oxygenation

时间窗: Baseline

Muscle oxygenation assessment will be performed using the Moxy monitor (Moxy, Fortiori Design LLC, Minnesota, USA).

Respiratory Muscle Strength

时间窗: Baseline

Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength will be evaluated.

Respiratory Muscle Endurance

时间窗: Baseline

Respiratory muscle endurance will be assessed by the POWERbreathe Wellness (POWERbreathe, Inspiratory Muscle Training (IMT) Technologies Ltd., Birmingham, UK) device and the respiratory muscle endurance test at increased threshold load.

Dyspnea

时间窗: Baseline

Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.

Clinical symptoms

时间窗: Baseline

The COPD Assessment Test will be evaluated. This scale scored on a 0-5 point scale to assess symptoms associated with COPD. As the score increases, the symptom increases.

次要结局

  • Pulmonary function (Forced vital capacity (FVC)(Baseline)
  • Pulmonary function (Forced expiratory volume in the first second (FEV1)(Baseline)
  • Pulmonary function (FEV1 / FVC)(Baseline)
  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(Baseline)
  • Pulmonary function (Peak flow rate (PEF))(Baseline)

研究者

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

Musa Güneş

Principal Investigator, PhD

Karabuk University

研究点 (1)

Loading locations...

相似试验