Effects of Farinelli's Breathing Exercise on Cardiorespiratory Fitness and Symptoms in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Forced expiratory volume in 1 second (FEV1) change
研究概览
简要总结
This study was to investigate the effect of Farinelli's breathing exercise on pulmonary function, respiratory muscle strength, aerobic capacity, impact of COPD questionnaires, cytokines, and oxidative stress in patients with Chronic Obstructive Pulmonary Disease (COPD).
详细描述
Sixteen patients with COPD (GOLD I) with mild and moderate (GOLD II) severity aged 51 - 80 years old who visited at the outpatient examination room, Phramongkutklao Hospital divided into 2 groups; diaphragmatic breathing group (DB; n=8) and Farinelli's breathing group (FB; n=8). Participants in each group were administered to complete breathing exercise 5 times per week for 8 weeks. Physiological data and pulmonary function (FVC, FEV1, PEF, FEV1/FVC, FEF25-75%, MVV, VC, TV, IRV, ERV and IC), respiratory muscle strength (MIP and MEP), aerobic capacity (6-MWD and VO2max), impact of COPD questionnaire (mMRC and CAT), cytokine (TNF-α and IL-6), and oxidative stress (MDA) were analyzed during Pre- and Post-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 51 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COPD who treated in Phramongkutklao Hospital
- •Have a history of smoking
- •FEV1 predicted after bronchodilator more than 50%
- •No change in medication in 4 weeks
- •No history of acute exacerbation in 4 weeks
- •No history of cardiac disease.
排除标准
- •Recurrent of acute exacerbation
- •Cannot participate at least 80% of training program (≤ 32 sessions of 40 sessions)
- •Unwilling to continue practicing.
结局指标
主要结局
Forced expiratory volume in 1 second (FEV1) change
时间窗: Change from Baseline Forced expiratory volume in 1 second at 8 weeks.
FEV1 is the volume of air exhaled in the first second under force after a maximal inhalation. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1 was showed in liters.
Inspiratory capacity (IC) change
时间窗: Change from Baseline Inspiratory Capacity at 8 weeks.
IC is the amount of air that can be inhaled after the end of a normal expiration. It is, therefore, the sum of the tidal volume and inspiratory reserve volume. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. IC was showed in liters.
Peak Expiratory Flow (PEF) change
时间窗: Change from Baseline Peak Expiratory Flow at 8 weeks.
PEF is the amount and rate of air that can be forcefully breathed out of the lungs. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. PEF is measured in liters/seconds.
Force Vital Capacity (FVC) change
时间窗: Change from Baseline Force Vital Capacity at 8 weeks.
FVC is the total volume of air that can be exhaled during a maximal forced expiration effort. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FVC is measured in liters.
Inspiratory Reserve Volume (IRV) change
时间窗: Change from Baseline Inspiratory Reserve Volume at 8 weeks.
IRV is the maximal volume of air inhaled from end-inspiration. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. IRV is measured in liters.
Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) change
时间窗: Change from Baseline Forced Expiratory Flow from 25% to 75% of vital capacity (FEF25-75%) at 8 weeks.
FEF25-75% is the average flow from the point at which 25 percent of the FVC has been exhaled to the point at which 75 percent of the FVC has been exhaled. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEF25-75% is measured in liters/seconds.
Tidal Volume (TV) change
时间窗: Change from Baseline Tidal Volume at 8 weeks.
TV is the volume of air inhaled or exhaled during each respiratory cycle. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. TV is measured in liters.
Expiratory Reserve Volume (ERV) change
时间窗: Change from Baseline Expiratory Reserve Volume at 8 weeks.
ERV is the maximal volume of air exhaled from end-expiration. The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. ERV is measured in liters.
The ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) change
时间窗: Change from Baseline The ratio of forced expiratory volume in 1 second to forced vital capacity at 8 weeks.
It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The participants were asked to wear a nose clip while sitting on a chair, and the researcher gave the participants the step-by-step protocol to prevent an incorrect maneuver. For the FVC maneuver, three cycles of slow normal breathing were performed before demonstrating forced inspiration and expiration. FEV1/FVC was showed in percentage.
Maximal Voluntary Ventilation (MVV) change
时间窗: Change from Baseline Maximum Voluntary Ventilation at 8 weeks.
The participants were asked to inhale and exhale quickly and forcefully for 10 seconds. Maximal Voluntary Ventilation (MVV) were measured in liters/minutes.
Impact of COPD change
时间窗: Change from Baseline Impact of COPD at 8 weeks.
The impact of COPD was assessed using the mMRC and the CAT. The mMRC has a 5-point (0-4) scale based on the severity of dyspnea, whereas the CAT is a patient-completed instrument to assess and quantify the quality of life and burden of the symptoms in patients with COPD. It consists of eight questions, each of which had a semantic 6-point (0-5) differential scale, providing a total score of up to 40 points. The scores 0-10, 11-20, 21-30, and 31-40 represented mild, moderate, severe, and very severe clinical impact, respectively.
Respiratory muscle strength change
时间窗: Change from Baseline respiratory muscle strength at 8 weeks.
Respiratory muscle strength was assessed by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in cmH2O. The participants were in a sitting position using a portable handheld mouth pressure meter (i.e., MicroRPM) with a nose clip. For the MIP measurement, the participants were asked to exhale until they felt no air remaining in their lungs (starting with the functional residual capacity \[FRC\] point), then held the device on their mouth and inhaled forcefully for 1-2 seconds. For the MEP measurement, the participants were asked to inhale until their lungs were completely filled with air (starting with the total lung capacity \[TLC\] point), then they kept the device on their mouth and exhaled forcefully for 1-2 seconds
次要结局
- Cytokines change(Change from baseline cytokines at 8 weeks.)
- Malondialdehydes (MDA) change(Change from baseline Malondialdehydes at 8 weeks.)
- Aerobic capacity change(Change from Baseline aerobic capacity at 8 weeks.)
研究者
Wannaporn Tongtako, Ph.D.
Principal investigator
Chulalongkorn University