Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

5 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

44

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Pakistan
    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 54000
        • Werving
        • Bashir hospital sialkot, fatima hospital
        • Contact:
        • Hoofdonderzoeker:
          • humera urfan, MSPT WH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Vanderbilt Orthostatic symptom score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Riphah International University

Onderzoekers

  • Hoofdonderzoeker: Masooma Saleem, MSPT WH, Riphah International University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 augustus 2025

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 september 2026

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Riphah/G-III/RCR&AHS/B45-068

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren