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Not yet recruiting NCT07435532

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

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: breather device, incentive spirometer.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

  • Device breather 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 quick
  • Other incentive spirometer
    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 wi

Primary outcome measures

  • Modified Medical Research Council (mMRC) Dyspnea Scale [Time frame: 1st day]
  • Spirometry using a calibrated incentive spirometer: [Time frame: 1st day]
  • COPD Assessment Test (CAT) [Time frame: 1st day]
  • 6 Minute Walk Test (6MWT): To evaluate exercise tolerance. [Time frame: 1st day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Riphah International University — Lahore

Publications

  • Elsayed, M., et al. (2025).

Identifiers

NCT: NCT07435532 · Tabinda Jabeen · 64229 · 64229

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗