Breathing Exercises in Asthma During Pregnancy

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04674943
Collaborator
(none)
24
1
2
3.8
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Breathing exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Breathing Exercises on Asthmatic Pregnant Females
Actual Study Start Date :
Sep 25, 2020
Actual Primary Completion Date :
Jan 15, 2021
Actual Study Completion Date :
Jan 20, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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

Experimental: 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)

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riphah International University Rawalpindi Federal Pakistan 44000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Suman Sheraz, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04674943
Other Study ID Numbers:
  • REC/00702 Saba Seemab
First Posted:
Dec 19, 2020
Last Update Posted:
Mar 23, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 23, 2021