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临床试验/NCT06176742
NCT06176742招募中不适用

Comparative Effects of Active Cycle Breathing Technique and Bubble Positive Expiratory Pressure Device in Asthmatic Patients

Riphah International University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Dyspnea 12 Tool

研究概览

简要总结

The study gap is that in previous studies the effects of bubble-PEP in different diseases have been studied but it's never been studied in asthmatic patients, so the reason behind this study is to see effects of bubble-PEP in Asthmatic Patients.

详细描述

The aim of this study was to determine the effect of Bubble-PEP device compared to ACBT in asthmatic patients. This study will be Randomized Clinical trial, Subject diagnosed with asthma meeting predetermined inclusion and exclusion criteria and will be divided into two groups. The baseline treatment for both groups would be diaphragmatic breathing exercises. While group A will be treated with ACBT and group B will be treated with bubble-PEP device. Each subject will receive 18 sessions with 3 treatments per week. Post treatment values will be recorded after the session and recorded values will be analyzed using SPSS 25

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, Investigator)

入排标准

年龄范围
31 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 31 to 40 years
  • Male & Female
  • Mild Asthmatic Patients
  • Able to perform techniques
  • Those who have never taken therapies for asthma before.
  • Chronic Asthma

排除标准

  • Patients with hypertension
  • Cardiac diseases
  • Any rib fracture
  • Previously taken instructions regarding this.
  • Any other unstable medical conditions

结局指标

主要结局

Dyspnea 12 Tool

时间窗: Up to 24 weeks

Dyspnea 12 is a valid and reliable measure of breathlessness in patients. It measures the current level of a patients breathlessness severity, incorporating both physical and affective aspects and does not depend on activity limitation. D-12 consists of 12 descriptor items on a scale of none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items. The time reference period captures the current level of breathlessness experienced by patients as opposed to specifically on the day of the test or in response to a specific activity. Data will be calculated before and after treatment with the help of outcome measure tools.

Breathlessness, Cough, and Sputum Scale (BCSS)

时间窗: Upto 24 weeks

The breathlessness, cough and sputum scale (BCSS) is used to predict patient exacerbation by evaluating common symptoms. The BCSS tool measures the patients self reported symptoms in real time. BCSS is a patient-reported outcome measure that asks patients to rate the severity of the three symptoms, each on a 5-point scale; from 0 to 4 the higher scores indicate more severe symptoms. Item scores are summed to yield a total score. Data will be calculated before and after treatment with the help of outcome measure tools.

Pulmonary Function Test

时间窗: Upto 24 weeks

Pulmonary function tests measure how much air you can exhale, and how quickly. There are several types of pulmonary function graphs that show data from the tests. The test which will be used is FEV1/FVC. This is the amount of air exhaled in the first second, compared with the total amount of air exhaled. It's given as a fraction (ratio) or a percentage. In general, the higher the FEV1/FVC, the better. This test will be done using Spirometer. Data will be calculated before and after treatment with the help of outcome measure tools.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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