Clinical trial NCT04674943: Breathing Exercises in Asthma During Pregnancy
Official title: Effects of Breathing Exercises on Asthmatic Pregnant Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Pregnancy
Keywords: Asthma
Forced Expiratory volume in 1 sec (FEV1)
Forced Vital capacity (FVC)
Peak Expiratory flow rate
Pregnancy
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Peak expiratory flow rate (PEFR)
timeFrame: 4 weeks
measure: Forced vital capacity (FVC)
timeFrame: 4 weeks
measure: Forced expiratory volume in 1sec (FEV1)
timeFrame: 4 weeks
measure: FVC/FEV1
timeFrame: 4 weeks
measure: Asthma Control Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Quality of life questionnaire (Short form 36) - SF 36
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Murphy VE. Managing asthma in pregnancy. Breathe (Sheff). 2015 Dec;11(4):258-67. doi: 10.1183/20734735.007915.
citation: Tan KS, Thomson NC. Asthma in pregnancy. Am J Med. 2000 Dec 15;109(9):727-33. doi: 10.1016/s0002-9343(00)00615-x.
citation: Labor S, Dalbello Tir AM, Plavec D, Juric I, Roglic M, Pavkov Vukelic J, Labor M. What is safe enough - asthma in pregnancy - a review of current literature and recommendations. Asthma Res Pract. 2018 Dec 27;4:11. doi: 10.1186/s40733-018-0046-5. eCollection 2018.
citation: Evaristo KB, Mendes FAR, Saccomani MG, Cukier A, Carvalho-Pinto RM, Rodrigues MR, Santaella DF, Saraiva-Romanholo BM, Martins MA, Carvalho CRF. Effects of Aerobic Training Versus Breathing Exercises on Asthma Control: A Randomized Trial. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2989-2996.e4. doi: 10.1016/j.jaip.2020.06.042. Epub 2020 Aug 6.