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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05586217
Other study ID # REC/0332 Muhadsa Chaudhary
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 10, 2022
Est. completion date December 10, 2022

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

EFFECTS OF INCENTIVE SPIROMETRY ON DYSPNEA AND CHEST CLEARANCE IN ASTHMATIC PATIENTS DURING SEASONAL SMOG


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 10, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
INCENTIVE SPIROMETRY
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.
Active cycle of breathing
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

Locations

Country Name City State
Pakistan Iettefaq hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Dyspnea-12 in Dyspnea-12 we use spirometer to check out the dyspnea. 12 weeks
Other Cough and Sputum assessment questionnaire in cough and sputum assessment questionnaire we use spirometer to check out the chest clearance. 12 weeks
Primary Asthma Control test In asthma control test we use spirometer to check out the respiratory functions. 12 weeks
Primary 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.
12 weeks
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