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

NCT04994028 | Completed DMC

• 1 other identifier: REC/Lhr/20/0301 Uzma Batool
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspnea; Pregnancy Related

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Conventional treatment that include behavioral and life style modification and dyspnea prevention education

Other: Conventional treatment

conventional treatment with volume Spirometry and deep breathing

EXPERIMENTAL

Conventional treatment along with volume Spirometry and deep breathing exercise

Other: conventional treatment with volume Spirometry and deep breathing

Interventions

Conventional treatment OTHER

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.

Conventional treatment

conventional treatment with volume Spirometry and deep breathing OTHER

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.

conventional treatment with volume Spirometry and deep breathing

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

Related Publications (6)

• Kolomanska D, Zarawski M, Mazur-Bialy A. Physical Activity and Depressive Disorders in Pregnant Women-A Systematic Review. Medicina (Kaunas). 2019 May 26;55(5):212. doi: 10.3390/medicina55050212.

  PMID: 31130705 BACKGROUND

• Jensen D, Ofir D, O'Donnell DE. Effects of pregnancy, obesity and aging on the intensity of perceived breathlessness during exercise in healthy humans. Respir Physiol Neurobiol. 2009 May 30;167(1):87-100. doi: 10.1016/j.resp.2009.01.011. Epub 2009 Feb 7.

  PMID: 19450766 BACKGROUND

• Bidad K, Heidarnazhad H, Pourpak Z, Ramazanzadeh F, Zendehdel N, Moin M. Frequency of asthma as the cause of dyspnea in pregnancy. Int J Gynaecol Obstet. 2010 Nov;111(2):140-3. doi: 10.1016/j.ijgo.2010.05.024. Epub 2010 Aug 12.

  PMID: 20708180 BACKGROUND

• Chiron B, Laffon M, Ferrandiere M, Pittet JF, Marret H, Mercier C. Standard preoxygenation technique versus two rapid techniques in pregnant patients. Int J Obstet Anesth. 2004 Jan;13(1):11-4. doi: 10.1016/S0959-289X(03)00095-5.

  PMID: 15321433 BACKGROUND

• Nurcahyani AS, Runjati R, Nugraheni SA. Giving Belly Breathing Technique and Positive Affirmation of Stress and Cortisol Hormone Levels in Third Trimester Pregnant Women. 2020. 77. Fiskin G, Sahin NH. Effect of diaphragmatic breathing exercise on psychological parameters in gestational diabetes: A randomised controlled trial. European Journal of Integrative Medicine. 2018;23:50-6

  BACKGROUND

• Armstrong CO. Post-op incentive spirometry: Why, when, & how. Nursing. 2017 Jun;47(6):54-57. doi: 10.1097/01.NURSE.0000516223.16649.02. No abstract available.

  PMID: 28538354 BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fareeha Kausar, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 6, 2021
• Study Start: October 13, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 15, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)