Breathing Exercises in Asthma During Pregnancy

Asthma in Pregnancy Clinical Trial

Official title:

Effects of Breathing Exercises on Asthmatic Pregnant Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674943
• Other study ID #: REC/00702 Saba Seemab
• Status: Completed
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 20, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Pregnancy

Intervention

Other:
• Breathing exercises
Breathing exercises as well as Buteyko technique and Papworth relaxation method was performed as relaxation technique. All exercises were performed 15rep 3 sets for 15 min.

Locations

Country	Name	City	State
Pakistan	Riphah International University	Rawalpindi	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View 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. Review. — View Citation

Murphy VE, Gibson PG. Asthma in pregnancy. Clin Chest Med. 2011 Mar;32(1):93-110. doi: 10.1016/j.ccm.2010.10.001. Epub 2010 Dec 17. Review. — View Citation

Murphy VE. Managing asthma in pregnancy. Breathe (Sheff). 2015 Dec;11(4):258-67. doi: 10.1183/20734735.007915. Review. — View Citation

Tan KS, Thomson NC. Asthma in pregnancy. Am J Med. 2000 Dec 15;109(9):727-33. Review. — View Citation

Wang H, Li N, Huang H. Asthma in Pregnancy: Pathophysiology, Diagnosis, Whole-Course Management, and Medication Safety. Can Respir J. 2020 Feb 22;2020:9046842. doi: 10.1155/2020/9046842. eCollection 2020. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak expiratory flow rate (PEFR)	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.	4 weeks
Primary	Forced vital capacity (FVC)	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.	4 weeks
Primary	Forced expiratory volume in 1sec (FEV1)	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.	4 weeks
Primary	FVC/FEV1	FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65).	4 weeks
Primary	Asthma Control Questionnaire	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.	4 weeks
Secondary	Quality of life questionnaire (Short form 36) - SF 36	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.	4 weeks