Effects of Resonant Breathing on Blood Pressure, Heart Rate and Perceived Stress
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a randomized, parallel-group controlled trial conducted in community rehabilitation centers in Lahore, Pakistan. A total of 50 participants diagnosed with stage I hypertension will be enrolled and allocated into two groups using a computer-generated randomization sequence with allocation concealment.
Participants in both groups will undergo standard physiotherapy consisting of general warm-up exercises and stretching, performed under supervision three times per week for eight weeks. The intervention group will additionally receive resonant breathing training, delivered as a structured breathing exercise performed for approximately 20 minutes per session.
Resonant breathing is a slow-paced breathing technique performed at approximately 4.5-7 breaths per minute with equal inhalation and exhalation phases. It is intended to improve autonomic balance by enhancing parasympathetic activity and reducing sympathetic nervous system dominance, thereby potentially improving cardiovascular and psychological outcomes.
Outcome assessments will be conducted at baseline and after 8 weeks. Primary outcomes include systolic blood pressure, diastolic blood pressure, heart rate, and perceived stress.
Blood pressure and heart rate will be measured using a validated automated digital sphygmomanometer. Perceived stress will be assessed using the Perceived Stress Scale (PSS-10).
Statistical analysis will be performed using SPSS version 26. Within-group comparisons will be analyzed using paired t-tests, while between-group comparisons will be assessed using independent t-tests. Effect size will be calculated using Cohen's d, with statistical significance set at p < 0.05.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Punjb
-
Lahore, Punjb, Pakistán
- Different Commuinty Center in Lahore
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults age 30-65 years
- Patients with hypertension stage I
- Patients with no serious comorbidities
- Not currently in any breathing therapy or rehabilitation programs
Exclusion Criteria:
- Age under 30 or over 65
- Patients with severe hypertension (stage II or III)
- Patients with serious comorbidities
- Patients taking medicines affecting blood pressure or heart rate
- Current use of tobacco or materials that may have an effect on blood pressure or stress level
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: Experimental Group
Group A: Will undergo a traditional physical therapy exercise program along with an eight-week resonant breathing program, with 20 minutes of supervised practice, three times a week.
|
Resonant breathing, or Coherent Breathing, is a slow, rhythmic technique focusing on equal inhales and exhales (often 5-6 seconds each) to calm the nervous system, improve heart rate variability (HRV), and reduce stress by aligning breath with heart rhythms.
|
|
Comparador de placebos: Control group
Group B: Will continue with the baseline physiotherapy intervention (general warm-up exercises and stretching) throughout the study period, with no resonant breathing or specific breathing exercises included.
|
Resonant breathing, or Coherent Breathing, is a slow, rhythmic technique focusing on equal inhales and exhales (often 5-6 seconds each) to calm the nervous system, improve heart rate variability (HRV), and reduce stress by aligning breath with heart rhythms.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure
Periodo de tiempo: 8 week
|
Blood pressure will be measured using a cuff wrapped around your upper arm.
|
8 week
|
|
heart rate
Periodo de tiempo: 8 week
|
To measure heart rate, find your pulse on your wrist or neck, count beats for 15 or 30 seconds, then multiply to get beats per minute (bpm)
|
8 week
|
|
perceived stress
Periodo de tiempo: 8 week
|
Perceived Stress Scale (PSS) scoring involves answering 10 (or 14/4) questions on a 0 (never) to 4 (very often) scale, then reversing scores for specific items (4, 5, 7, 8 for PSS-10) before summing them to get a total score (0-40 for PSS-10), with higher scores meaning more perceived stress, generally falling into low (0-13), moderate (14-26), and high (27-40) categories, though it's a self-assessment tool, not a diagnostic one.
|
8 week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maryum Khan, MS, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- Spruill TM. Chronic psychosocial stress and hypertension. Curr Hypertens Rep. 2010 Feb;12(1):10-6. doi: 10.1007/s11906-009-0084-8.
- Scott SB, Whitehead BR, Bergeman CS, Pitzer L. Combinations of stressors in midlife: examining role and domain stressors using regression trees and random forests. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):464-75. doi: 10.1093/geronb/gbs166. Epub 2013 Jan 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Syeda Fatima Zaheer Rizvi
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. .