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Dyspnea During PregnancyNCT07365163

Breathing Exercises Versus Incentive Spirometry in Third-Trimester Pregnancy

A study testing Deep Breathing Exercises and Volume-Oriented Incentive Spirometry in people with Dyspnea During Pregnancy and Physiological Changes in Pregnancy, run by University of Lahore at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
Deep Breathing Exercises and Volume-Oriented Incentive Spirometry
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
5 Apr 2025to 8 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • - 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

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Department of Physical Therapy, The University of Lahore

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Comparative Effects of Deep Breathing Exercises and Volume-oriented Incentive Spirometry on Dyspnea, Functional Endurance, and Pulmonary Function During the Third Trimester of Pregnancy

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.

Read the detailed description

This study was a randomized controlled trial designed to evaluate and compare the effects of two non-pharmacological respiratory interventions in women during the third trimester of pregnancy. Physiological changes during pregnancy, such as diaphragmatic elevation and increased oxygen demand, can contribute to dyspnea and reduced functional endurance. Safe and effective breathing interventions may help alleviate these symptoms without pharmacological risk.

Eligible pregnant women in their third trimester who met the inclusion criteria were recruited and randomly allocated into two intervention groups using a randomization method. Participants in Group A received a structured deep breathing exercise program, which focused on slow, controlled inhalation and exhalation techniques performed under supervision. Participants in Group B received volume-oriented incentive spirometry training, which encouraged sustained maximal inspiration using a standard incentive spirometer device.

Both interventions were administered according to a predefined protocol over the study period. Outcome measures were assessed at baseline and after completion of the intervention period. Primary outcomes included the assessment of dyspnea severity. Secondary outcomes included measures of functional endurance and pulmonary function.

The study was conducted in accordance with ethical standards and received approval from the institutional ethics review committee. All participants provided informed consent prior to participation. The findings of this study are intended to contribute to evidence-based physical therapy practice by identifying effective, low-risk breathing interventions for managing dyspnea and improving respiratory function during the third trimester of pregnancy.

Being tested
Deep Breathing Exercises, Volume-Oriented Incentive Spirometry
Keywords
Physical Therapy, Deep Breathing Exercises, Incentive Spirometry, Pregnancy, Third Trimester, Dyspnea
Medical subject headings
Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Breathing ExercisesOther

    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.

  • Volume-Oriented Incentive SpirometryDevice

    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.

Study groups in NCT07365163
Study groupRoleWhat they receive
Deep Breathing Exercise GroupExperimentalParticipants 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.
Receives: Other: Deep Breathing Exercises
Incentive Spirometry GroupExperimentalParticipants assigned to this arm performed volume-oriented incentive spirometry exercises using a standard incentive spirometer according to a predefined protocol during the intervention period.
Receives: Device: Volume-Oriented Incentive Spirometry

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Forced Expiratory Volume in One Second (FEV₁)

    Pulmonary function was assessed using spirometry by measuring Forced Expiratory Volume in one second (FEV₁). FEV₁ is reported in liters, with higher values indicating better pulmonary function.

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

  2. Forced Vital Capacity (FVC)

    Pulmonary function was assessed using spirometry by measuring Forced Vital Capacity (FVC). FVC is reported in liters, with higher values indicating better pulmonary function.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start5 Apr 2025
  3. Primary completion5 Jul 2025
  4. Study completion8 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to one of two parallel intervention groups: a deep breathing exercise group or a volume-oriented incentive spirometry group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07365163
Sponsor's protocol ID
PHRI/IREB/26/01/0023
Status last verified
Jan 2026
First submitted
4 Jan 2026
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared because this study was conducted as a university-based academic research project with data collected for thesis purposes. The informed consent obtained from participants did not include provisions for public data sharing, and the dataset contains sensitive personal health information. Data will be stored securely at the institution and used only for academic and research purposes in accordance with institutional ethics approval.

Publications

  • ZAHRA, M. S., SHIMAA, T. T., YOUSSEF, M. S., & EMAD, M. T. (2021). Effect of Deep Breathing on Functional Capacity among Healthcare Workers Wearing FFP2/N95 Filtering Facepiece Respirators. The Medical Journal of Cairo University, 89(September), 1699-1706.

  • Yüksel, F., Guzel, N. A., Taspinar, B., & Balaban, A. (2020). Relationship between trunk muscle endurance, pulmonary function, and respiratory muscle strength in healthy individuals. Türk Fizyoterapi ve Rehabilitasyon Dergisi, 31(3), 255-262.

  • Villarta Jr, R. L., & Asaad, A. S. (2014). Sample Size Determination in an Epidemiologic Study using the EpiTools Web-Based Calculator. Acta Medica Philippina, 48(1).

  • 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.

  • 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.

    PubMed 34556964
  • Sewa, D. W., & Ong, T. H. (2014). Pulmonary function test: spirometry. Proceedings of Singapore Healthcare, 23(1), 57-64.

  • 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.

  • 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.

  • 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)].

  • 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.

  • 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.

    PubMed 26894090
  • Hamilton DM, Haennel RG. Validity and reliability of the 6-minute walk test in a cardiac rehabilitation population. J Cardiopulm Rehabil. 2000 May-Jun;20(3):156-64. doi: 10.1097/00008483-200005000-00003.

    PubMed 10860197
  • Gosselink R. Controlled breathing and dyspnea in patients with chronic obstructive pulmonary disease (COPD). J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):25-33. doi: 10.1682/jrrd.2003.10.0025.

    PubMed 15074451
  • Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.

    PubMed 25311596
  • Felton M, Hundley VA, Grigsby S, McConnell AK. Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol. Hypertens Pregnancy. 2021 Feb;40(1):81-87. doi: 10.1080/10641955.2020.1869250. Epub 2021 Jan 19.

    PubMed 33463384

Questions about this trial

What is this clinical trial studying?

A study testing Deep Breathing Exercises and Volume-Oriented Incentive Spirometry in people with Dyspnea During Pregnancy and Physiological Changes in Pregnancy, run by University of Lahore at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Endurance (time frame: Baseline and at the end of the intervention period (approximately 6 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365163, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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