Breathing Exercises in Asthma During Pregnancy

Not Applicable

Completed

• Conditions: Asthma in Pregnancy
• Interventions: Other: Breathing exercises

• Registration Number: NCT04674943
• Lead Sponsor: Riphah International University

Brief Summary

The aim of this research is to determine the effects of breathing exercises on asthmatic pregnant females. A randomized controlled trial will be done for which the calculated sample size is 24. Non probability purposive sampling technique will be used and the subjects will be randomly divided in two groups, with one group undergoing pharmacological management where as breathing exercises will be provided to the other group. Lung volumes and capacities as well as quality of life will be assessed through questionnaire in order to determine the effect of breathing exercises in patients with asthma.

Detailed Description

Asthma is defined as chronic inflammatory condition of airways, characterized by periodic episodes of wheezing, cough, chest tightness, shortness of breath and which are often worse at night. This causes hyper-responsiveness of airways and flow of air obstruction leading to breathing difficulty. Asthma in pregnancy is a common risk factor for fetal and maternal complications. Asthma also effects outcomes of pregnancy and pregnancy affects asthma severity which has being currently being examined.

Approximately 50% of asthmatic pregnant females 25 percent experience a worsening of asthma control at some stage during pregnancy, and most of them take corticosteroids for the management of acute and chronic exacerbation. Pathogenesis of asthma during pregnancy is entirely related to the physiological and pathological changes .Uterine enlargement causes hormonal changes during pregnancy directly or indirectly Asthmatic women have an increased ratio of associated co-morbidities which have direct effect on it where by increasing risk of perinatal outcomes. Pregnancy associated with asthma affects women in many ways. Hormonal imbalances occurring during pregnancy affects lungs as well as sinuses. Increased estrogen causes nasal congestion during the 3rd trimester. A rise in progesterone may cause a feeling of shortness of breath. Its important to identify or diagnose asthma being a major cause of shortness of breath during pregnancy. Breathing exercises includes nasal breathing, diaphragmatic breathing, deep pursed lip breathing. They have beneficial effects, such as betterment in health related (QOL)quality of life ,decreasing anxiety ,depression, improving asthma symptoms, the treatment using relief medication, occurrence of exacerbations, and hyperresponsiveness of airways.

Global Initiative for Asthma(GINA GUIDELINES 2019)illustrated that non pharmacological management such as patient's education, breathing exercises and relaxation techniques can be used as an adjunct to asthma pharmacotherapy. Breathing exercises includes nasal breathing, diaphragmatic breathing, deep pursed lip breathing. They have beneficial effects, such as betterment in health related (QOL)quality of life, decreasing anxiety ,depression, improving asthma symptoms, the treatment using relief medication, occurrence of exacerbations, and hyperresponsiveness of airways in patients with asthma. Literature reviewed from different search engines shows that there are limited studies available regarding non pharmacological management of asthma during pregnancy so Current study is planned to assess if non pharmacological management such as breathing exercise techniques will help improve asthma symptoms exacerbation as well as quality of life following regular plan of exercises and relaxation techniques collectively.

Study Timeline

• Study Start: 2020-09-25
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Maternal age 20-40years
• Gestational week 13 to 28 weeks
• Asthma in women with mild and intermittent asthma
• Asthma in women with active mild and persistent asthma

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Exclusion Criteria

• Patents with any psychological disorder
• Patients with neurological, musculoskeletal, cardiac and pulmonary disease and physical impairments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing exercise group	Breathing exercises	1. Pursed lip breathing 15 reps x 3 sets) 2: Diaphragmatic breathing (15 reps x 3 sets) 3:Lateral costal breathing 15 reps x 3 sets)

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire	4 weeks	Asthma Control questionnaire is a self-reported subjective outcome measurement tool that is used to measure the sufficiency of asthma symptom control and changes in asthma symptoms. It is 5 point scale with scores ranging from 0 to 5 for each item. The greater the score of Asthma Control questionnaire, the better the prognosis and outcome.
Peak expiratory flow rate (PEFR)	4 weeks	Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Forced vital capacity (FVC)	4 weeks	Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
FVC/FEV1	4 weeks	FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).
Forced expiratory volume in 1sec (FEV1)	4 weeks	Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal.

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaire (Short form 36) - SF 36	4 weeks	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health which indicates quality of life with regard to different health domains.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Rawalpindi, Federal, Pakistan