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临床试验/NCT06968273
NCT06968273尚未招募不适用

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Capacity Assessments in Patients With COPD Undergoing a Cardiovascular and Strength Training Program

University of Extremadura1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年5月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Change in muscle oxygen saturation (%)

研究概览

简要总结

This experimental pre-post intervention study aims to evaluate the effect of a respiratory physiotherapy and combined strength and cardiovascular training program on muscle oxygen saturation and functional capacity in patients with Chronic Obstructive Pulmonary Disease (COPD). Oxygenation of the intercostal, quadriceps, and triceps surae muscles will be assessed using near-infrared spectroscopy (NIRS) during standard physical performance tests (6-Minute Walk Test and 30-Second Chair Stand Test). Additional functional parameters and quality of life will be recorded pre- and post-intervention. The results will contribute to optimizing rehabilitation programs and monitoring intensity and progress through muscle oxygenation data.

详细描述

This experimental pre-post study investigates the effects of a combined respiratory physiotherapy and physical training program on muscle oxygen saturation and functional capacity in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). COPD is a highly prevalent condition with a progressive impact on functional capacity, muscle performance, and quality of life. It is associated with systemic repercussions, including skeletal muscle dysfunction and oxygen transport limitations, which impair tolerance to physical activity.

The study will evaluate the acute and cumulative effects of a structured, supervised intervention including respiratory physiotherapy techniques, cardiovascular training, and progressive resistance training. Measurements will be taken before and after the intervention period to assess changes in muscle oxygen saturation-measured using near-infrared spectroscopy (NIRS) devices (Moxy Monitor)-in key muscle groups (intercostal, quadriceps, and triceps surae).

Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) and the 30-Second Chair Stand Test (30CST). Additional variables including inspiratory and expiratory pressures, pulmonary function (FEV1/FEV6), heart rate variability, dyspnea, lower limb fatigue, and quality of life (COPD Assessment Test) will also be recorded.

The intervention consists of 20 hospital-based sessions over four weeks (five sessions per week). The protocol is designed to reflect real clinical settings and aims to provide evidence for the feasibility, safety, and functional relevance of combining respiratory and musculoskeletal rehabilitation strategies in COPD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Age ≥18 years
  • Clinical diagnosis of COPD
  • Medically cleared for physical exercise

排除标准

  • Decompensated heart failure or exercise-limiting comorbidities
  • Cognitive impairment or legal incapacity to consent
  • Inability to perform physical tasks

结局指标

主要结局

Change in muscle oxygen saturation (%)

时间窗: From baseline to end of intervention (4 weeks)

Measured in intercostal, quadriceps, and triceps surae muscles using NIRS (Moxy Monitor) during 6MWT and 30CST, before and after the 4-week intervention.

次要结局

  • Perceived dyspnea and lower limb fatigue (Borg Scale)(From baseline to after the 4-week intervention)
  • FEV1/FEV6 ratio (portable COPD Vitalograph)(From baseline to after the 4-week intervention)
  • Heart rate variability and max/min heart rate (Polar system + Kubios HRV)(From baseline to after the 4-week intervention)
  • Quality of life (COPD Assessment Test - CAT)(From baseline to after the 4-week intervention)
  • Distance covered in 6-Minute Walk Test (6MWT)(From baseline to after the 4-week intervention)
  • Number of repetitions in the 30-Second Chair Stand Test(From baseline to after the 4-week intervention)
  • Maximal inspiratory and expiratory pressures (Pimax and Pemax)(From baseline to after the 4-week intervention)

研究者

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

Alejandro Caña Pino

Investigator

University of Extremadura

研究点 (1)

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