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

NCT07579026 | Recruiting

• 1 other identifier: Riphah/G-III/RCR&AHS/B45-068
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthostatic Hypotension; Heart Rate; Blood Pressure

Keywords

pregnancy; blood pressure; vital signs; orthostatic intolerance; postural orthostatic tachycardia syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  6 weeks

• 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

  6 weeks

• 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

  6 weeks

Study Arms (2)

Diaphragmatic breathing exercises

EXPERIMENTAL

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

educational retraining

ACTIVE COMPARATOR

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

educational retraining OTHER

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.

educational retraining

diaphragmatic breathing exercise OTHER

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

Diaphragmatic breathing exercises

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bashir hospital sialkot, fatima hospital

Sialkot, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 34246578 BACKGROUND

• Goodman BP. Treatment updates in postural tachycardia syndrome. Current Treatment Options in Neurology. 2020;22:1-13.

  BACKGROUND

• 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.

  PMID: 38958137 BACKGROUND

• Morgan K, Smith A, Blitshteyn S. POTS and pregnancy: A review of literature and recommendations for evaluation and treatment. International Journal of Women's Health. 2022:1831-47.

  BACKGROUND

• 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.

  PMID: 31743851 BACKGROUND

MeSH Terms

Conditions

Hypotension, Orthostatic; Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Masooma Saleem, MSPT WH

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

imran amjad, phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: August 31, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)