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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Dyspnea, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Conventional treatment
* Other: conventional treatment with volume Spirometry and deep breathing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment<br>Conventional treatment that include behavioral and life style modification and dyspnea prevention education | Other: Conventional treatment<br>* 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.<br>|
| Experimental: conventional treatment with volume Spirometry and deep breathing<br>Conventional treatment along with volume Spirometry and deep breathing exercise | Other: conventional treatment with volume Spirometry and deep breathing<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified dyspnea Borg scale | 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) | 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) | 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 |