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NCT Number: NCT07365163

Breathing Exercises Versus Incentive Spirometry in Third-Trimester 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.

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Key information

Conditions

Dyspnea During Pregnancy Dyspnea Pathological Conditions, Signs and Symptoms Physiological Changes in Pregnancy Reduced Functional Endurance Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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

Exclusion criteria

  • - 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Functional Endurance

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

    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.

Secondary outcomes

  1. Forced Expiratory Volume in One Second (FEV₁)

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

    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.

  2. Forced Vital Capacity (FVC)

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

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

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Collaborators

  • University of Lahore Hospital (ULH)

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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