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临床试验/NCT06407011
NCT06407011进行中(未招募)不适用

Effects of Swedish Massage Prior Circuit Breathing Training on Asthma Control and Respiratory Function in Patients With Asthma

Chulalongkorn University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Asthma Control Test : ACT

研究概览

简要总结

The objective of this study was to determine the effects of Swedish massage prior circuit breathing training on asthma control and respiratory function in patients with asthma.

详细描述

Thirty patients with asthma aged 20-65 years were randomized into 3 groups: the control group (CON; n=10), the Circuit Breathing Training group (CBT; n=10), and the Swedish Massage prior to Circuit Breathing Training group (SBT; n=10). Participants in the CON group carried out their daily routine without receiving any training program. The CBT group received circuit breathing training sessions lasting thirty minutes each, three times a week for twelve weeks, while the SBT group received a Swedish massage (20 minutes) before circuit breathing exercises (30 minutes) three times a week for twelve weeks. Physiological data, pulmonary function, respiratory muscle strength, cytokine levels, Asthma Control Test scores, Visual Analogue Scale scores, chest expansion, and muscle flexibility variables were analyzed during the pre-test, post-test at 6 weeks, and post-tests at 12 weeks. Two-way repeated measures ANOVA was used to compare the variables between each test and between groups. Statistical significance was defined as p < .05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Being a male or female patient with asthma who is between 20 and 65 years old.
  • Being a patient who has been diagnosed by a doctor with asthma for at least 6 months.
  • The severity of the disease has been assessed at levels 2 to 4, meaning the volume of air expelled in the first second of breathing quickly and with full force (Forced Expiratory Volume in one second; FEV1) is between 80% and 30% on the date of data collection. This has been certified by a doctor, and the patient is using medication according to the normal treatment plan.
  • Must not have other respiratory diseases such as tuberculosis, lung cancer, emphysema, chronic obstructive pulmonary disease (COPD), etc.
  • Should not have received exercise training for more than 20 minutes at a time, 3 days/week, or more in the past 6 months before participating in the research.
  • Having no communication problems.
  • The sample volunteers to participate in the research and agrees to sign the consent form to participate in the research.

排除标准

  • Being a patient who has a history of asthma caused by exercise (Exercise-Induced Asthma).
  • In case of a force majeure event that makes it impossible to continue participating in the research, such as injury from an accident or illness, etc.
  • Participating in less than 80 percent of the training sessions (28 times out of 36 times) for the breathing training group and the group that practiced breathing together with massage.
  • Unwillingness to continue participating in the research.

结局指标

主要结局

Asthma Control Test : ACT

时间窗: Change from baseline Asthma Control Test : ACT at 6 and 12 weeks.

The Asthma Control Test (ACT) consists of 5 questions designed to assess asthma symptoms over the past 4 weeks. A score out of 25 points is given, with a high score indicating good asthma control. A score lower than 20 points indicates that the disease is not well controlled.

Pulmonary function (Maximal voluntary ventilation; MVV)

时间窗: Change from baseline MVV at 6 and 12 weeks.

The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). During the MVV maneuver, participants were instructed to demonstrate in rapid and forceful inhalation and exhalation for a duration of 10 seconds. MVV will be reported in liter per minute (L/min).

The Mini Asthma Quality of Life Questionnaire: Mini AQLQ

时间窗: Change from baseline The Mini Asthma Quality of Life Questionnaire: Mini AQLQ at 6 and 12 weeks.

The Mini Asthma Quality of Life Questionnaire (Mini AQLQ) aims to assess changes in life satisfaction related to health status over the past 2 weeks. It consists of a total of 15 questions divided into 4 areas: Signs and symptoms: 5 items, Environmental management: 3 items, Emotion management: 3 items, and Performance of daily activities: 4 items.

Pulmonary function (Forced vital capacity; FVC)

时间窗: Change from baseline FVC at 6 and 12 weeks.

The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FVC will be reported in liter (L).

Pulmonary function (Forced Expiratory Volume in one second; FEV1)

时间窗: Change from baseline FEV1 at 6 and 12 weeks.

The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1 (L) will be reported in liter (L).

Pulmonary function (The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs; FEV1/FVC)

时间窗: Change from baseline FEV1/FVC at 6 and 12 weeks.

The participants were instructed to sit on a chair and wear a nose clip. The researcher provided them with a detailed set of instructions to ensure they performed the maneuver correctly according to guidelines of the American Thoracic Society (ATS). Prior to demonstrating forced inspiration and expiration, the participants were asked to perform three cycles of slow normal breathing as part of the FVC maneuver. FEV1/FVC will be reported in percent (%).

Respiratory muscle strength

时间窗: Change from baseline Respiratory muscle strength at 6 and 12 weeks.

Respiratory muscle strength was evaluated by measuring Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) in centimeters of water (cmH2O). The participants were seated and utilized a portable handheld mouth pressure meter (MicroRPM), along with a nose clip. To assess MIP, participants were instructed to exhale until they emptied their lungs at the point of functional residual capacity (FRC). Participants held the device to their mouth and forcefully inhaled for 1-2 seconds. For the measurement of MEP, participants were directed to inhale until their lungs were completely filled with air, starting from the total lung capacity (TLC) point. Participants were asked to maintain the device on their mouth and forcefully exhaled for 1-2 seconds.

次要结局

  • Fractional exhaled nitric oxide(Change from baseline Fractional exhaled nitric oxide at 6 and 12 weeks.)
  • Chest expansion(Change from baseline chest expansion at 6 and 12 weeks.)
  • Trunk extension(Change from baseline trunk extension at 6 and 12 weeks.)
  • Trunk flexion(Change from baseline trunk flexion at 6 and 12 weeks.)
  • Neck flexion(Change from baseline neck flexion at 6 and 12 weeks.)
  • Blood chemical data test(Change from baseline concentration of cytokines in serum of interleukin-4 (IL-4), interleukin-5 (IL-5), and interleukin-13 (IL-13) at 6 and 12 weeks.)
  • Neck extension(Change from baseline neck extension at 6 and 12 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wannaporn Tongtako, Ph.D.

Principal investigator

Chulalongkorn University

研究点 (2)

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