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临床试验/NCT06893445
NCT06893445尚未招募不适用

The Effect of Deep Tissue Massage on Respiratory Parameters in People with Asthma

Jagiellonian University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
2
主要终点
Assessment of change of lung vital capacity

研究概览

简要总结

Bronchial asthma, as a chronic inflammatory disease of the respiratory tract, significantly reduces the quality of life of patients. Standard treatment includes pharmacotherapy, but a holistic approach, including manual therapies, can support pharmacological therapy, reducing the need for drugs.

The aim of the research is to verify whether deep tissue massage (DTM) techniques applied to the chest significantly affect respiratory parameters in people with asthma. The study is the next stage of the study conducted on healthy people. After obtaining positive results in the study involving people not suffering from respiratory diseases, the next step is to examine people with, in this case, bronchial asthma. It is important to determine whether the use of this form of manual therapy can bring benefits in the context of improving respiratory functions, reducing respiratory muscle tension and relieving subjective symptoms associated with asthma, such as shortness of breath or limitations in everyday functioning.

The hypothesis assumes that DTM techniques can have a bigger effect on the respiratory system than classic massage (CM).

The study is a randomized controlled trial, where participants will be randomly assigned to one of two groups: the study group (subjected to DTM) or the control group (subjected to CM). Before and after the massage intervention, participants will undergo spirometry to assess the changes in respiratory parameters. The obtained data will then be analyzed for effects on respiratory parameters and differences between both groups.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •diagnosed with bronchial asthma
  • •stable health condition, allowing participation in the study
  • •informed consent to participate in the study

排除标准

  • •acute or chronic comorbidities that may affect the results (e.g. COPD, heart failure, cancer)
  • •any chest surgery performed within the last 6 months
  • •contraindications to massage (e.g. skin infections, wounds)
  • •pregnancy
  • •participation in other clinical trials in the last 3 months

研究组 & 干预措施

Deep Tissue Massage Group

Experimental

The one session of deep tissue massage will be performed. The patient's positions will be changed depending on the specificity of used techniques. The following techniques will be used: • Shifting the rectus abdominis m., • Stretching of the fascia within the costal arches, • trigger points compression (30-60 s). • Stretching of the chest fascia, superficially with forearm or fingertips on intercostal muscles, • "filleting" the pectoral muscles, • "hook and stretch" with the proximal phalanges of the fingers 2-4 and the forearm • "filleting" between the pectoral muscles and the deltoids, • Releasing the lateral edge of the scapula using the fingers and stretching the tissues, Releasing the medial edge of the scapula using the fingers and the weight of the patient, • "hook and stretch" of the trapezius muscle, • Subsequently, the patient will take a prone position. • Stretching of the levator scapulae and supraspinatus muscles using the fist, forearm and elbow will be performed.

干预措施: Deep Tissue Massage (Procedure)

Classic Massage Group

Active Comparator

The one session of classic massage will be performed. The massage will be performed with moderate force. The entire procedure will take about 15-20 min. The sequence of standard classic massage techniques will be used in standard way and patterns.

干预措施: Classic massage (Procedure)

结局指标

主要结局

Assessment of change of lung vital capacity

时间窗: twice: before and immediately after procedure administration in both groups

The vital capacity of the lungs will be assessed with spirometer. The subject stood with legs hip-width apart. For each measurement, disposable cardboard mouthpieces will be used. The examined person holds the device vertically with both hands. At the examiner's command, subject will take in as much air as possible, then tightly biet the mouthpiece with his mouth, and with all of their strength, exhale air into the device for as long as possible. The subject will have only 1 attempt-measured values were recorded with an accuracy of 50 mL.

Assessment of change of chest circumference

时间窗: twice: before and immediately after procedure administration in both groups

The chest circumference will be measured with a measuring tape, wrapped horizontally around the chest at the level of the xiphoid process. The subject stand with feet hip-width apart, arms hanging along the body. At the command, the subject will take a maximum breathe in (first measurement) and exhale to the maximum for the next (second measurement). Obtained values will be recorded with an accuracy of 0.5 cm.

Assessment of change of blood oxygen saturation

时间窗: twice: before and immediately after procedure administration in both groups

Testing blood oxygen saturation will be performed in a sitting position with digital pulseoximeter. The device will be put on the second finger of the left hand each time. The highest value displayed by the pulseoximeter within 30 s will be recorded with an accuracy of 1%.

Asessment of change of Peak Expiratory Flow (PEF)

时间窗: twice: before and immediately after procedure administration in both groups

Dynamic spirometry test will be performed with spirometer to assess the peak expiratory flow (PEF) measured in liters per second \[l/s\]. The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.

Assessment of change of Forced Vital Capacity

时间窗: twice: before and immediately after procedure administration in both groups

The forced vital capacity (FVC), measured in liters will be assessed with spirometer. The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ".

Assessment of change of Maximum Expiratory Flow

时间窗: twice: before and immediately after procedure administration in both groups

Assessment of the maximum expiratory flow (MEF), measured in liters per second will be performed with spirometer. The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.

Assessment of change of Forced Expiratory Volume in one second

时间窗: twice: before and immediately after procedure administration in both groups

Assessment of the forced expiratory volume in 1 s (FEV1) measured in literswill be performed with spirometer. The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carry out the following command: "Breathe calmly. On my command, breathe in as much as possible, as quickly as possible, as intensively as possible, and while at the top of the inhalation, without waiting, breathe out as hard and as long as possible ". This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.

Assessment of change of Maximum Voluntary Ventilation

时间窗: twice: before and immediately after procedure administration in both groups

Assessing the maximum voluntary ventilation (MVV) measured in liters per minute will be performed with spirometer. The subject will sit with his legs on the floor-hip joint flexed at an angle of 70o-90o and carried out the following command: "Breathe calmly. On my command, inhale and exhale as quickly and as deeply as possible for 15 s until you hear the 'stop' command. This cycle will be performed at least 3 times obtaining 3 measurements and the mean value will be calculated.

次要结局

未报告次要终点

研究者

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

Bartosz Trybulec

Assistant professor

Jagiellonian University

研究点 (2)

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