Effects of Breathing Retraining Exercises in Pregnant Females With Postural Orthostatic Tachycardia Syndrome.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Imran Amjad, PhD
- Número de teléfono: 03324390125
- Correo electrónico: imran.amjad@riphah.edu.pk
Ubicaciones de estudio
-
-
Punjab Province
-
Sialkot, Punjab Province, Pakistán, 54000
- Reclutamiento
- Bashir hospital sialkot, fatima hospital
-
Contacto:
- Masooma Saleem, MSPT WH
- Número de teléfono: 03320711342
- Correo electrónico: masooma.saleem@riphah.edu.pk
-
Investigador principal:
- humera urfan, MSPT WH
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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
|
|
Comparador activo: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Vanderbilt Orthostatic symptom score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Masooma Saleem, MSPT WH, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- Goodman BP. Treatment updates in postural tachycardia syndrome. Current Treatment Options in Neurology. 2020;22:1-13.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Disautonomías primarias
- Enfermedades del sistema nervioso autónomo
- Hipotensión
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Hipotensión Ortostática
- Intolerancia ortostática
- Síndrome de taquicardia ortostática postural
Otros números de identificación del estudio
- Riphah/G-III/RCR&AHS/B45-068
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .