Breathing Exercises Versus Incentive Spirometry in Third-Trimester Pregnancy

NCT07365163 | Completed

• 1 other identifier: PHRI/IREB/26/01/0023
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Shortness of breath (dyspnea) is commonly experienced during the third trimester of pregnancy due to physiological changes affecting the respiratory system. Non-pharmacological breathing interventions are often recommended to improve breathing comfort and functional capacity in pregnant women. This randomized controlled trial compared the effects of deep breathing exercises and volume-oriented incentive spirometry on dyspnea, functional endurance, and pulmonary function in women during the third trimester of pregnancy. Eligible participants were randomly assigned to one of two intervention groups. One group performed supervised deep breathing exercises, while the other group performed volume-oriented incentive spirometry exercises. Outcomes were measured before and after the intervention period and included the severity of dyspnea, functional endurance, and pulmonary function parameters. The results of this study aim to provide evidence regarding the effectiveness of simple, safe, and non-invasive breathing interventions for improving respiratory outcomes during late pregnancy.

Conditions

Dyspnea During Pregnancy; Physiological Changes in Pregnancy; Reduced Functional Endurance

Keywords

Physical Therapy; Deep Breathing Exercises; Incentive Spirometry; Pregnancy; Third Trimester; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Functional Endurance

  Functional endurance was assessed using the 6-Minute Walk Test (6MWT), which measures the total distance walked by a participant on a flat surface over six minutes. The outcome is reported in meters, with higher values indicating better functional endurance. The minimum possible value is 0 meters, and there is no predefined maximum value.

  Baseline and at the end of the intervention period (approximately 6 weeks)

Secondary Outcomes (2)

• Forced Expiratory Volume in One Second (FEV₁)

  Baseline and at the end of the intervention period (approximately 6 weeks)

• Forced Vital Capacity (FVC)

  Baseline and at the end of the intervention period (approximately 6 weeks)

Study Arms (2)

Deep Breathing Exercise Group

EXPERIMENTAL

Participants assigned to this arm performed a structured deep breathing exercise program consisting of slow, controlled inhalation and exhalation techniques under supervision during the intervention period.

Other: Deep Breathing Exercises

Incentive Spirometry Group

EXPERIMENTAL

Participants assigned to this arm performed volume-oriented incentive spirometry exercises using a standard incentive spirometer according to a predefined protocol during the intervention period.

Device: Volume-Oriented Incentive Spirometry

Interventions

Deep Breathing Exercises OTHER

Deep breathing exercises focused on diaphragmatic breathing with slow, deep inhalation followed by controlled exhalation. The exercises were performed according to a standardized protocol under supervision.

Deep Breathing Exercise Group

Volume-Oriented Incentive Spirometry DEVICE

Volume-oriented incentive spirometry involved slow, sustained maximal inspiration using an incentive spirometer device to encourage lung expansion and improve respiratory function, performed under supervision according to protocol.

Incentive Spirometry Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Participants aged between 18 and 40 years
• Blood pressure below 140/90 mmHg
• Not pregnant
• Primigravida women
• Participants in the third trimester of pregnancy
• Able to understand and follow instructions
• Willing to participate and provide informed consent

You may not qualify if:

• \- History of cardiovascular disorders
• History of respiratory disorders
• History of psychological disorders
• History of medical or surgical conditions involving the nose, throat, diaphragm, or lungs
• Any condition that could interfere with participation in breathing exercises or spirometry

Sponsors & Collaborators

• University of Lahore: lead
• University of Lahore Hospital (ULH): collaborator

Study Sites (1)

Department of Physical Therapy, The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (26)

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• Siraj, S., Israr, S., Jamshed, K., & Tahir, L. (2022). Incidence and Causes of Dyspnea in Pregnant Women: Experience from a Tertiary Care Hospital. Pakistan Journal of Chest Medicine, 28(4), 420-425.

  BACKGROUND

• Shetty N, Samuel SR, Alaparthi GK, Amaravadi SK, Joshua AM, Pai S. Comparison of Diaphragmatic Breathing Exercises, Volume, and Flow-Oriented Incentive Spirometry on Respiratory Function in Stroke Subjects: A Non-randomized Study. Ann Neurosci. 2020 Jul;27(3-4):232-241. doi: 10.1177/0972753121990193. Epub 2021 Mar 17.

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  BACKGROUND

• Rufaida, Z., Istiqomah, R., & Lestari, S. W. P. (2023). EFFECT OF DEEP BREATH RELAXATION ON THE ANXIETY AMONG THIRD TRIMESTER PREGNANT WOMEN IN MOJOKERTO DISTRICT, INDONESIA: A QUASI EXPERIMENT. Journal of Community Mental Health and Public Policy, 6(1), 41-47.

  BACKGROUND

• Rafea, A., Wagih, K., Amin, H., El-Sabagh, R., & Yousef, S. (2009). Flow-oriented incentive spirometer versus volume-oriented spirometer training on pulmonary ventilation after upper abdominal surgery. Egyptian Journal of Bronchology, 3(2), 110-118.

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• Pellegrim, C. (2022). Dyspnea, Level of Physical Activity and Social and Emotional Factors in Pregnant Women in the Context of the COVID-19 Pandemic in Portugal Universidade de Aveiro (Portugal)].

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• Moore, Y., Shotton, E., Brown, R., Gremmel, J., Lindsey, S., & Pankey, J. (2018). Effects of incentive spirometry on perceived dyspnea in patients hospitalized with pneumonia. MedSurg Nursing, 27(1), 19-37.

  BACKGROUND

• Kumar AS, Alaparthi GK, Augustine AJ, Pazhyaottayil ZC, Ramakrishna A, Krishnakumar SK. Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial. J Clin Diagn Res. 2016 Jan;10(1):KC01-6. doi: 10.7860/JCDR/2016/16164.7064. Epub 2016 Jan 1.

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  PMID: 12890299 BACKGROUND

• Elumalai, S., Suganthirababu, P., & Ramalingam, K. (2024). The Effect of Threshold Inspiratory Muscle Training Device and Incentive Spirometry Device for Dyspnoea among Third-Trimester Antenatal Women. Indian Journal of Physiotherapy & Occupational Therapy, 18.

  BACKGROUND

• Elsayed, S. H., Basset, W. K. M. A., & Fathy, K. A. (2015). Impact of active cycle of breathing technique on functional capacity in patient with bronchiectasis. International Journal of Therapies and Rehabilitation Research, 4(5), 287.

  BACKGROUND

• Ejikeme C, Nandakumar V, Gotur D. Respiratory physiological changes in pregnancy. Respir Med. 2025 Sep;246:108245. doi: 10.1016/j.rmed.2025.108245. Epub 2025 Jul 3.

  PMID: 40614834 BACKGROUND

• Dumitrascu-Biris D, Nzelu D, Dassios T, Nicolaides K, Kametas NA. Chronic hypertension in pregnancy stratified by first-trimester blood pressure control and adverse perinatal outcomes: A prospective observational study. Acta Obstet Gynecol Scand. 2021 Jul;100(7):1297-1304. doi: 10.1111/aogs.14132. Epub 2021 Mar 17.

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• Delgado, A., Marinho, G., Melo, R. S., Pinheiro, F., & Lemos, A. (2024). Effectiveness of breathing exercises during first stage of labor: A systematic review and meta-analysis. European Journal of Integrative Medicine, 68, 102370.

  BACKGROUND

• Chaudhary, S., Chaudhary, N. I., Ghewade, B., & Mahajan, G. (2020). The immediate effects of breathing exercises with acapella and incentive spirometer on preventing early pulmonary complications following cabg-a comparitive study. International Journal of Current Research and Review, 12(17), 51-58.

  BACKGROUND

• Bordeleau M, Vincenot M, Lefevre S, Duport A, Seggio L, Breton T, Lelard T, Serra E, Roussel N, Neves JFD, Leonard G. Treatments for kinesiophobia in people with chronic pain: A scoping review. Front Behav Neurosci. 2022 Sep 20;16:933483. doi: 10.3389/fnbeh.2022.933483. eCollection 2022.

  PMID: 36204486 BACKGROUND

• AMOLA, M., PAWARA, S., & KALRA, S. (2019). Effect of Inspiratory Muscle Training and Diaphragmatic Breathing Exercises on Dyspnea, Pulmonary Functions, Fatigue and Functional Capacity in Pregnancy during Third Trimester. Journal of Clinical & Diagnostic Research, 13(8).

  BACKGROUND

• Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.

  PMID: 27525116 BACKGROUND

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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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation to reduce assessment bias. Participants and care providers were not blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Physical Therapy Student

Model Details: Participants were randomly assigned to one of two parallel intervention groups: a deep breathing exercise group or a volume-oriented incentive spirometry group.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 26, 2026
• Study Start: April 5, 2025
• Primary Completion: July 5, 2025
• Study Completion: August 8, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)