- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07573683
Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Participants will be randomly assigned to an intervention group (aerobic exercise plus coherent breathing) or a control group (aerobic exercise only) and will undergo a 4-week program with 5 sessions per week.
Cardiopulmonary parameters-including blood pressure, heart rate, respiratory rate, and rate pressure product-will be measured, and quality of life will be assessed using the MINICHAL questionnaire at baseline, 2 weeks, and post-intervention. Data will be analyzed using SPSS version 21.0.
The study aims to determine whether coherent breathing provides additional benefits, offering a cost-effective, non-pharmacological strategy for hypertension management in low-resource settings.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. A normal reading is less than 120 millimeters of mercury over less than 80 millimeters of mercury. Hypertension is a prevalent condition affecting approximately 1.28 billion individuals globally, with a significant burden observed in low- and middle-income countries such as Pakistan. Stage 1 hypertension is defined by a systolic blood pressure (SBP) between 130-139 mmHg or diastolic blood pressure (DBP) between 80-89 mmHg. High blood pressure causes no signs or symptoms, which is why healthcare providers call it a "silent killer." Non-pharmacological interventions, including aerobic exercise and breathing techniques, have shown promise in improving cardiopulmonary function and quality of life.
Coherent breathing is a controlled breathing technique that involves inhaling and exhaling at a steady, slow pace-typically around five to six breaths per minute, with each inhale and exhale lasting about six seconds. This study aims to evaluate the additional effects of coherent breathing techniques when combined with aerobic exercise, compared to aerobic exercise alone. A randomized controlled trial design will be employed. The study will be conducted over a period of 1 year at Foundation University College of Physical Therapy and Fauji Foundation Hospital Rawalpindi. Ethical approval will be obtained from ERC FUMC and IRC, and the trial will be registered with CBRC and the clinical trial registry. Data will be analyzed using SPSS version 21.0.
This study will fill a critical gap in the literature by assessing the additive benefits of coherent breathing in hypertension management. The findings may support cost-effective, non-pharmacological strategies in low-resource settings, contributing to improved public health outcomes
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Kainat Zahra, MSPT-CPPT
- Номер телефона: 03367343005
- Электронная почта: zahrakainat99@gmail.com
Учебное резервное копирование контактов
- Имя: Syeda Sumaira Batool, MSPT-CPT
- Номер телефона: 03328868680
- Электронная почта: sumaira.batool@fui.edu.pk
Места учебы
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Islamabad, Пакистан
- Рекрутинг
- Foundation University Islamabad
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Контакт:
- Syeda Sumaira Batool, MSPT-CPT
- Номер телефона: 03328868680
- Электронная почта: sumaira.batool@fui.edu.pk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Both male and female genders.
- Adults aged 30-65 years.
- Patients diagnosed with stage 1 hypertension 130-139/80-89mm Hg according to ACC/AHA 2017 guidelines.
- Mild to moderate physical activity level on IPAQ questionnaire.
- Individuals able to understand and follow the instructions.
Exclusion Criteria:
- Diagnosed uncontrolled hypertensive patients.
- Unstable angina, MI, heart failure, advanced CAD patients, COPD, Asthma.
- Severe neurological, musculoskeletal or gynecological conditions which limit participation in the study.
- Recent history of fracture.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Aerobic Exercises
This Group performs aerobic exercises as follows: Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing exercies for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 40 minutes TYPE: Aerobic exercises & simple breathing. A total of 20 sessions Five days per week for 4 weeks. |
Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min.
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Экспериментальный: Aerobic Exercises with coherent breathing
This group performs aerobic exercises combined with coherent breathing technique. Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 30 minutes TYPE: Aerobic exercises. Coherent Breathing technique for 10 minutes. TOTAL DURATION: 40 minutes Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 30 minutes TYPE: Aerobic exercises |
Coherent breathing technique involve consciously reducing the breathing rate, typically to fewer than 10 breaths per minute, often around 6 breaths per minute. Coherent breathing is performed for 10 minutes. Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a period of 30 min. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Heart Rate (beats per minute)
Временное ограничение: 04 weeks
|
Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.
|
04 weeks
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Systolic Blood Pressure (mmHg)
Временное ограничение: 04 weeks
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Measured using standardized sphygmomanometer at baseline and post-intervention.
|
04 weeks
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Diastolic Blood Pressure (mmHg)
Временное ограничение: 04 weeks
|
Measured using standardized sphygmomanometer at baseline and post-intervention.
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04 weeks
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Peripheral Oxygen Saturation (SpO₂, %)
Временное ограничение: 04 weeks
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Measured using pulse oximeter under resting conditions at baseline and post-intervention.
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04 weeks
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Respiratory Rate (breaths/minute)
Временное ограничение: 04 weeks
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Measured by direct observation at baseline and post-intervention.
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04 weeks
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Rate Pressure Product (HR × SBP)
Временное ограничение: 04 weeks
|
Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.
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04 weeks
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FUCP/CTR/2026/06
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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