Effectiveness of Volume Spirometry and Deep Breathing Exercise for Dyspnea During Third Trimester of Pregnancy

August 5, 2021 updated by: Riphah International University
During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Dyspnea is a common complaint in pregnancy related to change in respiratory centre threshold and sensitivity. Pregnant women who engaged in regular exercise have less pregnancy induced discomforts like dyspnea and leg cramps than who did not engage in exercise. During pregnancy women undergoes anatomical, mechanical and physiological changes to meet the demand of growing fetus. Purpose of this study was to evaluate the efficacy of volume Spirometry and breathing exercise on dyspnea in third trimester of pregnancy. Rationale of the study was to find the effects of volume Spirometry and breathing exercise on dyspnea with focus on method of deep breathing exercise and volume Spirometry and outcomes. Significance of this study was to improve functional capacity and quality of life in pregnancy induced dyspnea. Subjects were randomly allocated to either two groups both groups received baseline treatment while interventional group received volume Spirometry and deep breathing exercise. Estimated sample size of 48 divided into 24 in either group by randomization. Modified Borg scale and visual analog scale were used to collect the findings. Non-parametric tests were used and analyzed by using spss22.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Dera Ghazi Khan, Punjab, Pakistan, 32200
        • DHQ Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI 18.5-30
  • Primigravida and multigravida with 3rd trimester
  • Singleton and twin pregnancy

Exclusion Criteria:

  • Cardiac and respiratory disorders
  • Smoker
  • Obesity
  • Any type of allergy
  • Autoimmune disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional treatment
Conventional treatment that include behavioral and life style modification and dyspnea prevention education
Other: Conventional treatment
Behavioral and life style modification and dyspnea prevention education i.e. Sitting: Sit upright with back against chair, feet wide apart, leaning forward with arms on bedside table or on knees. Standing: Lean back against wall with feet slightly apart with head and shoulder relaxed. In Bed: Elevate head of the bed, support and elevate arms with pillow. Stairs: Lean forward with on banister when climbing stairs.
Experimental: conventional treatment with volume Spirometry and deep breathing
Conventional treatment along with volume Spirometry and deep breathing exercise
Other: conventional treatment with volume Spirometry and deep breathing
Group B or interventional group was received conventional treatment along with volume Spirometry and deep breathing exercise, total 5 breaths with 3sec inhalational breath hold for each breath at one session per day for volume Spirometry and for deep breathing exercise 10 times with breath hold 2sec at every session for 5 minutes 3 times per week for total duration of two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified dyspnea Borg scale
Time Frame: 2nd week
Modified Borg Dyspnea Scale is most commonly used to assess symptoms of breathlessness. It has a range from 0 to 10 (with 0 being no exertion and 10 being maximum effort).
2nd week
Modified Medical Research Council Dyspnea Scale (mMRC)
Time Frame: 2nd week
Questionnaire that consist of 5 statements about breathlessness. Grade0, get breathlessness only at strenuous exercise. Grade1, got breathlessness when hurrying on level ground. Grade2, walk slower than the people of my age on the level. Grade3, stop for breath after few minutes of walk on the level. Grade4, too breathlessness to leave the house when dressing or undressing.
2nd week
London chest activity of Daily Living questionnaire (LCADL)
Time Frame: 2nd week

It consist of four domains Selfcare, domestic activities, physical activities and leisure activities.

Selfcare, domestic, physical and leisure activities contains 4, 6, 2 and 3 items respectively. Each item is graded by numbers 0-5, 0 mean little or no dyspnea and 5 mean worst dyspnea.gy
2nd week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/20/0301 Uzma Batool

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy Related

Clinical Trials on Conventional treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe