Effects of Breathing Retraining Exercises in Pregnant Females With Postural Orthostatic Tachycardia Syndrome.

May 5, 2026 updated by: Riphah International University

Effects of Breathing Retraining Exercises on Heartrate, Blood Pressure and Orthostatic Intolerance in Pregnant Females With Postural Orthostatic Tachycardia Syndrome.

Postural orthostatic tachycardia POTS is characterized by excessive increase in heart rate when moving from lying to standing position, often accompanied by symptoms such as dizziness, fatigue, brain fog, lightheadedness, rapid heartbeat and palpitation.it most commonly effects the females of reproductive age and can be triggered by events like viral infections, trauma and hormonal changes. During pregnancy females may experience worsening of symptoms in first trimester due to hormonal changes and decreased blood volume later on in second and third trimester the blood volume begins to increase. However, breathing exercises helps to regulate the nervous system, improves parasympathetic activity and reduce sympathetic activity.

The study will be randomized clinical trial and will be conducted at Bashir hospital Sialkot and Fatima hospital Sialkot. The study will be completed in 10 months of duration after the approval of synopsis. Non probability convenience sampling will be used and 44 participants will be included in the study after randomization. The subjects will be divided into two groups. Group A (experimental group) will receive diaphragmatic breathing exercises whereas Group B (control group) will receive educational retraining whereas both groups will receive baseline treatments which includes progressive muscle relaxation techniques. The tools used for the study will be Vanderbilt orthostatic symptom score VOSS to evaluate orthostatic intolerance, blood pressure will be measured using non-invasive blood pressure measurement and pulse oximetry will be used to access the heart rate. After data completion data will be analyzed by using SPSS version 21.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postural orthostatic tachycardia POTS is characterized by excessive increase in heart rate when moving from lying to standing position, often accompanied by symptoms such as dizziness, fatigue, brain fog, lightheadedness, rapid heartbeat and palpitation.it most commonly effects the females of reproductive age and can be triggered by events like viral infections, trauma and hormonal changes. During pregnancy females may experience worsening of symptoms in first trimester due to hormonal changes and decreased blood volume later on in second and third trimester the blood volume begins to increase. However, breathing exercises helps to regulate the nervous system, improves parasympathetic activity and reduce sympathetic activity.

The study will be randomized clinical trial and will be conducted at Bashir hospital Sialkot and Fatima hospital Sialkot. The study will be completed in 10 months of duration after the approval of synopsis. Non probability convenience sampling will be used and 44 participants will be included in the study after randomization. The subjects will be divided into two groups. Group A (experimental group) will receive diaphragmatic breathing exercises whereas Group B (control group) will receive educational retraining whereas both groups will receive baseline treatments which includes progressive muscle relaxation techniques. The tools used for the study will be Vanderbilt orthostatic symptom score VOSS to evaluate orthostatic intolerance, blood pressure will be measured using non-invasive blood pressure measurement and pulse oximetry will be used to access the heart rate. After data completion data will be analyzed by using SPSS version 21.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 54000
        • Recruiting
        • Bashir hospital sialkot, fatima hospital
        • Contact:
        • Principal Investigator:
          • humera urfan, MSPT WH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Pregnant female between the age of 19 to 35 years.

    • Active standing results in a sustained increase in heart rate (HR) of at least 30 bpm or ≥120 bpm.
    • POTS patients with a subacute onset of lightheadedness, dizziness, and presyncope provoked by standing.
    • palpitations with chest discomfort, breathing difficulties, or feeling faint

Exclusion Criteria:

  • • Uncontrolled hypertension/pre-eclampsia

    • cardiovascular disorder
    • Patients with uncontrolled diabetes
    • Patient with Anemia, severe heart failure and neurodegenerative diseases.
    • Females with the history of deep venous thrombosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragmatic breathing exercises
The treatment group will receive diaphragmatic breathing exercise. Pregnant women will be asked to relax for 5 minutes in the supine posture. One hand will be placed on the abdomen, the other on the upper chest wall. When inhaling, the hand on the abdomen will move upward and the other hand remain as still as possible. When exhaling, the hand on the abdomen will move downwards. Inhale through the nose and exhale through the mouth. Pregnant ladies will be instructed to carefully exhale using controlled expiration. While the other hand will stay as still as possible. Following the breathing exercise, pregnant women will be asked to rest for 5 minutes. After learning the method, the exercises can be performed while sitting. Over the period of 30 days, the intervention group will be instructed to perform diaphragmatic breathing exercises for 5 minutes once a day.
Other: diaphragmatic breathing exercise
The treatment group will receive diaphragmatic breathing exercise. Pregnant women will be asked to relax for 5 minutes in the supine posture. One hand will be placed on the abdomen, the other on the upper chest wall. When inhaling, the hand on the abdomen will move upward and the other hand remain as still as possible. When exhaling, the hand on the abdomen will move downwards. Inhale through the nose and exhale through the mouth. Pregnant ladies will be instructed to carefully exhale using controlled expiration. While the other hand will stay as still as possible. Following the breathing exercise, pregnant women will be asked to rest for 5 minutes. After learning the method, the exercises can be performed while sitting. Over the period of 30 days, the intervention group will be instructed to perform diaphragmatic breathing exercises for 5 minutes once a day
Active Comparator: educational retraining
The control group will receive educational retraining. The participants will be asked to rise gradually from supine or sitting positions, particularly in the morning, after meals, and after urination/defecation. Avoid prolonged standing, high ambient temperatures, and excessive humidity. A daily hydration intake of at least 2.5 liters will be advised. Use of compression garments/ stocking to reduce peripheral pooling of lower limb.
Other: educational retraining
The control group will receive educational retraining. The participants will be asked to rise gradually from supine or sitting positions, particularly in the morning, after meals, and after urination/defecation. Avoid prolonged standing, high ambient temperatures, and excessive humidity. A daily hydration intake of at least 2.5 liters will be advised. Use of compression garments/ stocking to reduce peripheral pooling of lower limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vanderbilt Orthostatic symptom score
Time Frame: 6 weeks
It describes the following nine symptoms: mental clouding, brain fog, shortness of breath, palpitations, tremor, headache, chest tightness, blurred vision, and nausea. VOSS will help to evaluate if the symptoms will get severe, after tilting back. Participants will be asked to rate the expression of their symptoms on a scale of 0 to 10.
6 weeks
Non-invasive blood pressure measurement
Time Frame: 6 weeks
Non-invasive blood pressure (NIBP) measurement will be used by pressuring cuff around the arm or leg. The auscultatory approach will detect blood pressure by detecting the sound of the limb artery opening and closing. The oscillometer approach will measure the vibration of the cuff during pressurized air release. NIBP is considered as a gold standard test
6 weeks
Pulse oximetry
Time Frame: 6 weeks
Pulse oximeters are commonly used for the non-invasive, simultaneous measurement of hemoglobin oxygen saturation. They are reliable, accurate, relatively affordable, and portable. Pulse oximeters are commonly used to determine heart rate during rest and during activity
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Masooma Saleem, MSPT WH, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Riphah/G-III/RCR&AHS/B45-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on diaphragmatic breathing exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe