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CompletedNCT04994028Updated Aug 6, 2021

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

An interventional study of Conventional treatment and conventional treatment with volume Spirometry and deep breathing in Dyspnea and Pregnancy Related, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Oct 2020, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
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Study 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.

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Conditions studied

  • Dyspnea
  • Pregnancy Related

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03

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 46 is close to the median of 48 across 429 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Conventional treatment

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

    Other: Conventional treatment

  • 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

Interventions

  • OtherConventional 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.

  • Otherconventional 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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 2nd week

  2. 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.

    Time frame: 2nd week

  3. 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

    Time frame: 2nd week

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Study locations

1 site
  • DHQ Teaching Hospital
    Dera Ghazi Khan, Punjab 32200, Pakistan
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References and documents

Publications

  • 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. PubMed 31130705 ↗
  • 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. PubMed 19450766 ↗
  • 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. PubMed 20708180 ↗
  • 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. PubMed 15321433 ↗
  • 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
  • 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. PubMed 28538354 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04994028
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Oct 13, 2020
Primary completion
Jun 30, 2021
Completion
Jul 15, 2021
Last update
Aug 6, 2021

Study contacts

Fareeha Kausar, PP-DPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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