NCT04674943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

December 16, 2020

Last Update Submit

March 21, 2021

Conditions

Asthma in Pregnancy

Keywords

AsthmaForced Expiratory volume in 1 sec (FEV1)Forced Vital capacity (FVC)Peak Expiratory flow ratePregnancyQuality of life

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Quality of life questionnaire (Short form 36) - SF 36

    4 weeks

Study Arms (2)

Control group

NO INTERVENTION

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

Breathing exercise group

EXPERIMENTAL

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

Interventions

Breathing exercisesOTHER

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.

Breathing exercise group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is going to be conducted on female pregnant patients with asthma
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Federal, 44000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 21277452BACKGROUND

  • 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.

    PMID: 32184907BACKGROUND

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

    PMID: 27066119BACKGROUND

  • 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.

    PMID: 11137489BACKGROUND

  • 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.

    PMID: 30607253BACKGROUND

  • 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.

    PMID: 32773365BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 19, 2020

Study Start

September 25, 2020

Primary Completion

January 15, 2021

Study Completion

January 20, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)