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Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog

Primary Purpose

Shortness of Breath

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
INCENTIVE SPIROMETRY
Active cycle of breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shortness of Breath focused on measuring Spirometry,Asthma,Dyspnea and Chest clearance

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age group:30-45 Patients of bronchial Asthma Patients who have difficulty in breathing

Exclusion Criteria:

  • Age:<30 yrs->45 yrs Patients of COPD,Bronchiectasis,Pneumonia,Pulmonary TB or any other chronic lung disease.

Patients of HTN, IHD, patients of fever or any other chronic disease

Sites / Locations

  • Iettefaq hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Incentive Spirometry

Active Cycle of Breathing

Arm Description

12 weeks, 1 session per week; each session took about 1 hour.

Breathing Control Deep Breathing Exercises or Thoracic Expansion Exercises Huffing or Forced Expiratory Technique (FET)

Outcomes

Primary Outcome Measures

Asthma Control test
In asthma control test we use spirometer to check out the respiratory functions.
Incentive Spirometry
An incentive spirometer is a handheld medical device that measures the volume of our breath. It helps our lungs recover after surgery or lung illness, keeping them active and free of fluid.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2022
Last Updated
July 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05586217
Brief Title
Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog
Official Title
Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG
Detailed Description
Asthma is a serious and life threatening chronic respiratory disease that affects the quality of life of more than 23 million Americans- with exposure to air pollution. Air pollution can make asthma symptoms worse and trigger asthma attacks. Particle pollution can cause breathing problems. It's created when tiny bits of dust, dirt, smoke, soot, and other stuff hang in the air. The smaller the particles, the deeper they can get into the lungs and cause breath problems. Seasonal smog aggravates asthma, irritates the lungs, and makes it difficult to breathe. Long-term inflammation from breathing in too much ground-level ozone can permanently scar lung tissue. Smog with high levels of ozone is also particularly damaging for people with asthma. During seasonal smog asthma patients are more affected than normal people. Various consecutive treatments are used to treat the asthma patients for the improvement of quality of life. But at this check the effects of incentive spirometry on dyspnea and chest clearance in asthmatic patients. This study will be randomized controlled trial. This study will be conducted in Ittefaq Hospital Lahore. Subjects meeting the predetermined inclusion and exclusion criteria. Sample size will be 44 including both male and female. QUESTIONNAIRE used as subjective measurements and ASHMA CONTROL TEST as objective measurement. Dyspnea-12 will be used to check the dyspnea severity in asthma patients and asthma control test will be used to check asthma severity during seasonal smog. Cough and sputum assessment questionnaire will be used to check effectiveness of chest clearance. Subjects of one group will be treated with active cycle of breathing and incentive spirometry and the other group will be treated with only spirometry. Each group will receive 12 treatment sessions with one treatment session per week and it will take less than 1 hour. Pre- treatment reading of dynpnea-12, cough and sputum assessment questionnaire and asthma control test will be recorded. And post-treatment readings will also be recorded. Outcome variables will be dyspnea-12, incentive spirometry, cough and sputum assessment questionnaire and asthma control test. Most commonly used incentive spirometry to clear the dyspnea and chest clearance in asthma patients. Data will be analyzed on SPSS-25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shortness of Breath
Keywords
Spirometry,Asthma,Dyspnea and Chest clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Incentive Spirometry
Arm Type
Experimental
Arm Description
12 weeks, 1 session per week; each session took about 1 hour.
Arm Title
Active Cycle of Breathing
Arm Type
Active Comparator
Arm Description
Breathing Control Deep Breathing Exercises or Thoracic Expansion Exercises Huffing or Forced Expiratory Technique (FET)
Intervention Type
Other
Intervention Name(s)
INCENTIVE SPIROMETRY
Intervention Description
Sit up and hold the device. Then Place the mouthpiece spirometer in mouth and make a good seal over the mouthpiece with lips. Breathe out (exhale) normally. Breathe in (inhale) slowly. A piece in the incentive spirometer will rise as you breathe in. And try to get this piece to rise as high as you can. Usually, there is a marker placed by your doctor that tells you how big of a breath you should take. A smaller piece in the spirometer looks like a ball or disk. Your goal should be to make sure this ball stays in the middle of the chamber while you breathe in. If you breathe in too fast, the ball will shoot to the top. If you breathe in too slowly, the ball will stay at the bottom. Hold your breath for 3 to 5 seconds. Then slowly exhale.
Intervention Type
Other
Intervention Name(s)
Active cycle of breathing
Intervention Description
Breathe in and out gently through your nose if you can. If you cannot, breathe through your mouth instead. If you breathe out through your mouth, it's best to use breathing control with 'pursed lips breathing'. keep your shoulders relaxed. Try closing your eyes to help you to focus on your breathing and to relax. Breathing control should continue until the person feels ready to progress to the other stages in the cycle. Try to keep your chest and shoulders relaxed. At the end of the breath in, hold the air in your lungs for 2-3 seconds before breathing out. Breathe out gently and relaxed. Repeat 3 - 5 times. Sit up straight with chin tilted slightly up and mouth open. Take a slow deep breath to fill lungs about three quarters full. Hold breath for two or three seconds. Exhale forcefully, but slowly, in a continuous exhalation to move mucus from the smaller to the larger airways
Primary Outcome Measure Information:
Title
Asthma Control test
Description
In asthma control test we use spirometer to check out the respiratory functions.
Time Frame
12 weeks
Title
Incentive Spirometry
Description
An incentive spirometer is a handheld medical device that measures the volume of our breath. It helps our lungs recover after surgery or lung illness, keeping them active and free of fluid.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Dyspnea-12
Description
in Dyspnea-12 we use spirometer to check out the dyspnea.
Time Frame
12 weeks
Title
Cough and Sputum assessment questionnaire
Description
in cough and sputum assessment questionnaire we use spirometer to check out the chest clearance.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group:30-45 Patients of bronchial Asthma Patients who have difficulty in breathing Exclusion Criteria: Age:<30 yrs->45 yrs Patients of COPD,Bronchiectasis,Pneumonia,Pulmonary TB or any other chronic lung disease. Patients of HTN, IHD, patients of fever or any other chronic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sumera abdulhameed, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iettefaq hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
042
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Incentive Spirometry on Dyspnea and Chest Clearance in Asthmatic Patients During Seasonal Smog

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