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

NCT07435532 | Not Yet Recruiting DMC

• 2 other identifiers: Tabinda Jabeen64229
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD

Keywords

COPD; breather device; incentive spirometer

Outcome Measures

Primary Outcomes (4)

• Modified Medical Research Council (mMRC) Dyspnea Scale

  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.

  1st day

• Spirometry using a calibrated incentive spirometer:

  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

  1st day

• COPD Assessment Test (CAT)

  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.

  1st day

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

  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

  1st day

Study Arms (2)

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.

Device: breather 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.

Other: incentive spirometer

Interventions

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.

breather device

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.

incentive spirometer

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

• Elsayed, M., et al. (2025).

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Wajeeha Zia, phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wajeeha Zia, phd

CONTACT

03234500788; wajeeha.zia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)