The Effect of Manual Therapy Techniques on the Mobility of the Diaphragm in People With Asthma: Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Diaphragmatic excursion assessment with Ultrasonography
研究概览
简要总结
The mechanical alterations related to the overload of respiratory muscles observed in people with persistent asthma can lead to the development of musculoskeletal dysfunctions. Moreover, the produced lung hyperinflation and high lung volumes in the asthma crisis put the diaphragm at a disadvantage in terms of its length-tension curve and lowered its excursion and capacity to generate force. According to a preliminary study, manual therapy (MT) techniques can be used as adjunctive therapy in asthma treatment. The proposed protocol is the first randomized controlled clinical trial to assess MT's efficacy on the diaphragm's ZOA in conjunction with BRE in individuals with well controlled mild moderate and severe asthma. Many musculoskeletal and respiratory outcomes will be used to investigate the under-study therapies' impact.
详细描述
The diaphragm produces a craniocaudal movement of its dome during contraction, making it the most crucial breathing muscle due to its unique anatomical structure and contribution to minute ventilation (60%-80%). Patients with (COPD) or asthma often develop diaphragmatic dysfunction (DD). This DD is related to the mechanical linkage between its various parts, placing it at a mechanical disadvantage to the muscle fibers. The capacity of the diaphragm to elevate and extend the lower rib cage at the level of the zone of apposition is impaired by this pathological change. This change increases the work of breathing and weakens the diaphragm. People with moderate or severe asthma may experience pulmonary overstretching, which can lead to functional issues. How physiotherapy may increase the mechanical efficiency of the thoracic cage and the effectiveness of the respiratory muscles during breathing has been the main focus of studies in recent decades. Although the use of specific diaphragm MT techniques does not yet have sufficient research documentation, recently published studies reported that there are indications to support their positive effect on pulmonary rehabilitation. The efficacy of diaphragm MT methods has not been investigated in adults with asthma, although it has been investigated in pediatric asthma. The effect of diaphragms MT techniques in combination with BRE has not been investigated. The present study hypothesizes that the combination of the mentioned physiotherapy techniques will contribute positively to the length-tension relationship and mobility of the diaphragm and chest expansion in patients with asthma. Secondary positive improvements are expected in the domain of functionality, (b) the feeling of dyspnea, (c) disease control and (d) abnormal respiratory pattern. The amplification of the above in people with asthma using respiratory standards and applying diaphragm mobilization techniques will contribute to better disease management.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 - 60 years
- •Diagnosed with well controlled asthma (mild, moderate-severe) using spirometry
- •No acute exacerbation in the last two months
排除标准
- •Cardiopulmonary diseases
- •Previous cardiothoracic or abdominal surgery
- •Patients who have a recent history of the chest wall or abdominal trauma
- •Patients with unstable hemodynamic parameters (arterial pressure >140mmHg systolic and >90mmHg for diastolic inability to understand the verbal commands necessary for the outcome assessments
- •Pregnancy
- •Neurological diseases
- •Previous or parallel participation in interventional programs.
结局指标
主要结局
Diaphragmatic excursion assessment with Ultrasonography
时间窗: Change from baseline up to 6 weeks and up to 3 months
The M-mode line is placed at the posterior part of the diaphragm where there is maximal movement and excursion. On the right side, the liver acts as an acoustic window, and the diaphragm is easily identified as a hyperechoic curved line abutting the liver.
Chest wall expansion
时间窗: Change from baseline up to 6 weeks and up to 3 months
By placing the tape measure at the level of the axilla (about the level of the sternal angle of Louis), the level of the xiphoid process, or between the xiphoid process and the umbilicus, the therapist identifies the upper, middle, and lower chest wall expansion, respectively. The therapist should repeat the measurement at least three times for each level for higher fidelity.
次要结局
- Nijmegen Questionnaire(Change from baseline up to 6 weeks and up to 3 months)
- Asthma Control Test(Change from baseline up to 6 weeks and up to 3 months)
- Borg scale(Change from baseline up to 6 weeks and up to 3 months)
- Sf-12v2 questionnaire(Change from baseline up to 6 weeks and up to 3 months)
研究者
DIMITRIOS TSIMOURIS
Principal Investigator
University of West Attica