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临床试验/NCT07365163
NCT07365163已完成不适用

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

University of Lahore1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年4月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Functional Endurance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • - 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

排除标准

  • - 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

研究组 & 干预措施

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.

干预措施: Deep Breathing Exercises (Other)

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.

干预措施: Volume-Oriented Incentive Spirometry (Device)

结局指标

主要结局

Functional Endurance

时间窗: 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.

次要结局

  • 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))

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adnan Hashim

Doctor of Physical Therapy Student

University of Lahore

研究点 (1)

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