Breathing Exercises in Asthma During Pregnancy

NCT ID: NCT04674943

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma in Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

No physical therapy intervention was given. Only pharmacological treatment was provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Breathing exercise group

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)

Group Type EXPERIMENTAL

Breathing exercises

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suman Sheraz, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riphah International University

Rawalpindi, Federal, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21277452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32184907 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 27066119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11137489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30607253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32773365 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/00702 Saba Seemab

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.