跳至主要内容
临床试验/NCT07435532
NCT07435532尚未招募不适用

Comparative Effects of Breather Device and Incentive Spirometer on Dyspnea , Lung Function Tests and Quality of Life in Patients With Copd.

Riphah International University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月10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
80
试验地点
1
主要终点
Modified Medical Research Council (mMRC) Dyspnea Scale

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is characterized and defined by limitation of expiratory airflow. This can result from several types of anatomical lesions, including loss of lung elastic recoil and fibrosis and narrowing of small airways. Inflammation, edema, and secretions also contribute variably to airflow limitation.it is a preventable and treatable disease characterized by persistent airflow limitation and respiratory symptoms, leading to cough, dyspnea, muscle weakness and fatigue affecting overall well-being and quality of life. The Breather is a respiratory muscle training device strengthening both inspiratory and expiratory muscles by breathing against a set resistance, which can be increased in line with training progress while. Another technique with proven effect in improvement of respiratory function and lung expansion is the incentive spirometry. incentive spirometry is used to encourage deep breathing and effective coughing, to achieve maximum dilation of the bronchi and prevent and treat pulmonary complications such as atelectasis in COPD patients.

详细描述

This research of randomized clinical trial will evaluate the effects of breather device and incentive spirometer on dyspnea, lung function and quality of life in COPD patients by taking sample of 80 patients through non probability convenience sampling as per inclusion criteria. The patients will be allocated randomly into two groups. One group will receive breather device 2 sets of 10 breaths two times a day ,6 days a week for 2 weeks. While second group will receive incentive spirometer 20 minutes per session 30 breaths per set 5-6 times a day for 2 weeks. The patient will be asked to hold breath in for 2-3 seconds. Outcomes including Modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT) and 6-minute walk distance will be assessed at baseline and after the intervention period. The data will be analyzed by using SPSS

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
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Both male and female of age group between 45 to
  • •Patients with mild to moderate COPD
  • •Patients willing to participate.
  • •patients with ability to understand and follow the instructions.

排除标准

  • •Hemodynamically unstable patients
  • •Patients with other cardiorespiratory and neurological diseases.

研究组 & 干预措施

breather device

Active Comparator

Patient will assume a comfortable sitting position on chair; all limbs are rested and supported. The training begins using breather device with the easiest inhalation and exhalation resistances by rotating both the dials to number one. Each patient will be taught and trained to secure the mouthpiece with lips. A soft nose clip will be put on nose to occlude the nostrils and prevent air leaks. each patient will be asked to rapidly inhale, maintained a pause for two to three seconds and then quickly and forcefully exhale. The patient's stomach, rib cage, and neck muscles will be noticed and monitored during breathing in against resistance to make sure to relax the upper chest and shoulders. Then will ask the patient to exhale forcefully for two to three seconds while preventing puffing from the cheeks. The previous steps will be done for 2 sets of ten breaths two times per day, 6 days a week.

干预措施: breather device (Device)

incentive spirometer

Experimental

The preparation and positioning instructions for patients will be given to lose any tight clothing. ensure comforted position and explain treatment concisely. The patients will be asked to take a deep slow inspiration while lips fitted around mouthpiece of incentive spirometer. Visual feedback will be provided to the patient, such as a ball rising to a preset marker, to motivate them during the exercise. The patient will be instructed to get the planned flow at the preset amount. Then patient will be asked to maintain breathing in for 2-3 seconds.

干预措施: incentive spirometer (Other)

结局指标

主要结局

Modified Medical Research Council (mMRC) Dyspnea Scale

时间窗: 1st day

is a simple questionnaire used to assess the impact of breathlessness on daily activities. It's a 5-point scale ranging from Grade 1 (no breathlessness except with strenuous exercise) to Grade 5 (too breathless to leave the house). The scale is widely used to measure perceived respiratory disability and is valuable in evaluating the severity of breathlessness in various conditions like COPD.

Spirometry using a calibrated incentive spirometer:

时间窗: 1st day

An incentive spirometer is a handheld device used to help patients take slow, deep breaths, improving lung function and preventing complications like pneumonia, especially after surgery or illness. It encourages the lungs to expand and strengthen, and can also help clear mucus from the airways

COPD Assessment Test (CAT)

时间窗: 1st day

is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how these changes over time. It covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts, including physical activity, confidence, sleep, and energy.

6 Minute Walk Test (6MWT): To evaluate exercise tolerance.

时间窗: 1st day

The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The object of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway. Six minutes is a long time to walk.. You are permitted to slow down, to stop, and to rest as necessary. You may lean against the wall while resting, but resume walking as soon as you are able. You will be walking back and forth around the cones

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 (1)

Loading locations...

相似试验