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RecruitingNCT07579026Updated May 11, 2026

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

An interventional study of diaphragmatic breathing exercise and educational retraining in Orthostatic Hypotension, Heart Rate and Blood Pressure, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 19 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2025, registered May 2026).
  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
19 Years to 35 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Orthostatic Hypotension
  • Heart Rate
  • Blood Pressure

Keywords

  • pregnancy
  • blood pressure
  • vital signs
  • orthostatic intolerance
  • postural orthostatic tachycardia syndrome
03

In context

Hypotension, Orthostatic

155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.

This study's planned enrollment of 44 is above the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.

Browse Hypotension, Orthostatic studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Otherdiaphragmatic 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

  • Othereducational 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.

06

What researchers measure

Primary outcomes

  1. Vanderbilt Orthostatic symptom score

    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.

    Time frame: 6 weeks

  2. Non-invasive blood pressure measurement

    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

    Time frame: 6 weeks

  3. Pulse oximetry

    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

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Bashir hospital sialkot, fatima hospital
    Sialkot, Punjab Province 54000, Pakistan
    Recruiting
08

References and documents

Publications

  • Raj SR, Bourne KM, Stiles LE, Miglis MG, Cortez MM, Miller AJ, Freeman R, Biaggioni I, Rowe PC, Sheldon RS, Shibao CA, Diedrich A, Systrom DM, Cook GA, Doherty TA, Abdallah HI, Grubb BP, Fedorowski A, Stewart JM, Arnold AC, Pace LA, Axelsson J, Boris JR, Moak JP, Goodman BP, Chemali KR, Chung TH, Goldstein DS, Darbari A, Vernino S. Postural orthostatic tachycardia syndrome (POTS): Priorities for POTS care and research from a 2019 National Institutes of Health Expert Consensus Meeting - Part 2. Auton Neurosci. 2021 Nov;235:102836. doi: 10.1016/j.autneu.2021.102836. Epub 2021 Jun 30. PubMed 34246578 ↗
  • Goodman BP. Treatment updates in postural tachycardia syndrome. Current Treatment Options in Neurology. 2020;22:1-13.
  • Boris JR, Shadiack EC 3rd, McCormick EM, MacMullen L, George-Sankoh I, Falk MJ. Long-Term POTS Outcomes Survey: Diagnosis, Therapy, and Clinical Outcomes. J Am Heart Assoc. 2024 Jul 16;13(14):e033485. doi: 10.1161/JAHA.123.033485. Epub 2024 Jul 3. PubMed 38958137 ↗
  • Morgan K, Smith A, Blitshteyn S. POTS and Pregnancy: A Review of Literature and Recommendations for Evaluation and Treatment. Int J Womens Health. 2022 Dec 24;14:1831-1847. doi: 10.2147/IJWH.S366667. eCollection 2022. PubMed 36590760 ↗
  • Reilly CC, Floyd SV, Lee K, Warwick G, James S, Gall N, Rafferty GF. Breathlessness and dysfunctional breathing in patients with postural orthostatic tachycardia syndrome (POTS): The impact of a physiotherapy intervention. Auton Neurosci. 2020 Jan;223:102601. doi: 10.1016/j.autneu.2019.102601. Epub 2019 Nov 12. PubMed 31743851 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07579026
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 11, 2026
Start date
Aug 31, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
May 11, 2026

Study contacts

imran amjad, phd
Contact
imran.amjad@riphah.edu.pk
03324390125
Masooma Saleem, MSPT WH
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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