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临床试验/NCT07062939
NCT07062939尚未招募不适用

Comparative Effects of Manual Versus Mechanical Airway Clearance Techniques in Cystic Fibrosis

Riphah International University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年7月6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
入组人数
52
试验地点
1
主要终点
The Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

This study will help to establish evidence-based physiotherapy on postural drainage and ACBT against flutter with ACBT is better to improve sleep quality, adherence, dyspnea in patients with cystic fibrosis and which method can improve respiratory function, reduce the risk of complications after illness and additionally advancements in respiratory therapy can lead to improve sleep quality, individual preference and adherence and dyspnea.

详细描述

Cystic fibrosis (CF) is a genetic disorder that leads to the accumulation of thick mucus in the lungs and other organs, resulting in recurrent infections and progressive lung damage. This condition is due to mutations in the cystic fibrosis transmembrane conductance regulator CFTR gene, which governs the transport of chloride and other ions across cell membranes. CF affects a significant number of people worldwide, with certain genetic mutations leading to more severe manifestations of the disease. The management of CF is centered on clearing the airways of mucus to prevent infections and slow the progression of lung damage. Various studies have yielded inconsistent results regarding the comparative effectiveness of manual versus mechanical airway clearance techniques in improving pulmonary function tests (PFTs) in CF patients.

Despite the existing literature on postural drainage with ACBT in patient with cystic fibrosis, there is a significant research gap regarding the flutter and ACBT on the bases of outcomes in cystic fibrosis. Most studies have not adequately addressed the distinct needs and responses of flutter with ACBT on the basis of outcomes, leaving a void in understanding how these two intervention effect on sleep, adherence and dyspnea in the context of patients with cystic fibrosis. Closing this gap is essential for developing evidence-based and pulmonary rehabilitation techniques for this specific patient group.

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 (Investigator)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient having clinically diagnose Cystic fibrosis.
  • •Age 16-40 year.
  • •Both male and female.
  • •Subjects who are conscious and cooperative .

排除标准

  • •Rib fracture
  • •History of cardiac surgery.
  • •Subject with any Physical or Mental Disability
  • •Age less than 16 years

研究组 & 干预措施

postural drainage with ACBT

Experimental

postural drainage and active cycle breathing technique for 2 times a day for 30 min for 4 weeks

干预措施: postural drainage with ACBT (Other)

flutter with ACBT

Active Comparator

active cycle breathing technique with flutter for 30 min for 4 week and 2 times a day

干预措施: flutter with ACBT (Other)

结局指标

主要结局

The Pittsburgh Sleep Quality Index (PSQI)

时间窗: 4 weeks

This is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval, show the sleep quality duration and efficacy. Many of the aforementioned research employed the PSQI, the most commonly utilized sleep quality index. the validity and reliability of the PSQI in healthcare professionals, or even in high-pressure shift employees. The PSQI's validity and reliability in regularly planned, low-pressure groups, such as adults in good health who live in the vicinity, differed greatly from front-line COVID-19 healthcare personnel. The conventional test theory (CTT) serves as the primary foundation for the reliability and validity research on PSQI. While there is little to no link between the PSQI and problems including anger, nausea,stiffness, and urinary disorder, it does have a strong correlation with the Insomnia Severity Index, polysomnography, and other sleep quality indicators

The Shwachman-Kulczycki score

时间窗: 4 weeks

This is the first scoring system used in cystic fibrosis to assess disease severity and show the adherence to treatment. In the present study, the total Shwachman-Kulczycki score correlated positively with the scores for each of its four domains, and physical activity was the aspect that most influenced total score.

Borg dyspnea scale

时间窗: 4 weeks

The instruments provide a standard method for patients to select ratings of dyspnea on a scale based on descriptors that correspond to specific numbers

次要结局

  • The Breathlessness, Cough and Sputum Scale (BCSS)(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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