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NCT Number: NCT07435532

Comparative Effects of Breather Device and Incentive Spirometer in Patients With COPD

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both male and female of age group between 45 to 65.
  • Patients with mild to moderate COPD
  • Patients willing to participate.
  • patients with ability to understand and follow the instructions.

Exclusion criteria

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

Treatment and study plan

breather device

Device

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.

incentive spirometer

Other

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.

Primary outcomes

  1. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: 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.

  2. Spirometry using a calibrated incentive spirometer:

    Time frame: 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

  3. COPD Assessment Test (CAT)

    Time frame: 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.

  4. 6 Minute Walk Test (6MWT): To evaluate exercise tolerance.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Wajeeha Zia, phd

CONTACT

[email protected]

03234500788

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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