Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension (SPB-HTN)
Effect of Smartphone-Guided Paced Breathing Combined With Aerobic Exercise on Blood Pressure, Functional Capacity, and Quality of Life in Patients With Essential Hypertension
Przegląd badań
Status
Szczegółowy opis
Essential hypertension is one of the leading modifiable risk factors for cardiovascular morbidity and mortality worldwide. Despite the widespread use of antihypertensive medications, many patients continue to experience inadequate blood pressure control and persistent impairment in functional capacity and health-related quality of life. Therefore, complementary non-pharmacological interventions that improve cardiovascular regulation and promote long-term adherence are increasingly recommended as part of comprehensive hypertension management.
Slow paced breathing has been shown to reduce sympathetic nervous system activity, enhance parasympathetic modulation, improve baroreflex sensitivity, and lower arterial blood pressure. Smartphone-guided paced breathing applications provide visual and auditory cues that facilitate breathing at a controlled rate of approximately 5-6 breaths per minute while enabling convenient home-based practice and improving treatment adherence. Aerobic exercise is a well-established intervention for patients with hypertension and has demonstrated beneficial effects on blood pressure, endothelial function, cardiorespiratory fitness, exercise tolerance, and quality of life. Combining smartphone-guided paced breathing with aerobic exercise may produce additive or synergistic effects by simultaneously improving autonomic regulation and cardiovascular fitness.
This study is designed as a prospective, randomized, parallel-group controlled trial to investigate the effectiveness of smartphone-guided paced breathing combined with aerobic exercise in adults with essential hypertension. Eligible participants will be randomly assigned to one of three intervention groups: (1) smartphone-guided paced breathing combined with aerobic exercise, (2) aerobic exercise alone, or (3) smartphone-guided paced breathing alone. All participants will continue to receive their prescribed antihypertensive medications under the supervision of their treating physician throughout the study period.
The intervention period will last 12 weeks. Outcome assessments will be performed at baseline and at the completion of the intervention. The primary objective is to determine whether the combined intervention provides superior improvement in systolic and diastolic blood pressure compared with either intervention alone. Secondary objectives include evaluating changes in resting heart rate, functional capacity measured by the 6-Minute Walk Test (6MWT), and health-related quality of life assessed using the Short Form-12 (SF-12) questionnaire.
The findings of this study are expected to provide evidence regarding an accessible, low-cost, and technology-assisted rehabilitation strategy that may enhance non-pharmacological management of essential hypertension and improve cardiovascular health outcomes.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Shimaa Taha, PhD
- Numer telefonu: +201021088610
- E-mail: shimaa.taha@cu.edu.eg
Kopia zapasowa kontaktu do badania
- Nazwa: Mona Ziethar, Lecturer of Physical Therapy f
- Numer telefonu: +201151602624
- E-mail: monaamin028@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
Adults aged 40-50 years. Both males and females. Clinically diagnosed with essential (primary) hypertension confirmed by a physician.
Stage 1-2 hypertension (SBP 130-160 mmHg and/or DBP 80-100 mmHg) based on standardized clinical measurement.
Duration of diagnosed hypertension between 6 months and 5 years. Stable on antihypertensive medication for at least 4 weeks prior to enrollment, with no planned medication changes.
Medically stable and cleared for participation in moderate-intensity exercise. Able to understand instructions and independently perform smartphone-guided breathing exercises.
Willing to participate and provide written informed consent.
Exclusion Criteria:
Secondary hypertension (e.g., renal, endocrine, or medication-induced hypertension).
Severe or uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg). History of major cardiovascular events (e.g., myocardial infarction within the past 6 months, unstable angina, uncontrolled arrhythmias, or decompensated heart failure).
Chronic respiratory diseases affecting exercise tolerance (e.g., chronic obstructive pulmonary disease [COPD] or severe asthma).
Neurological, musculoskeletal, or orthopedic conditions that limit safe participation in walking or exercise training.
Cognitive impairment or psychiatric disorders that affect comprehension or adherence to the study protocol.
Participation in a structured exercise or pulmonary rehabilitation program within the previous 3 months.
Heavy smoking. Pregnancy or lactation. Contraindications to exercise testing or training according to the American College of Sports Medicine (ACSM) guidelines.
Anticipated changes in antihypertensive medication during the study period.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Combined Intervention
Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks, in addition to their usual antihypertensive medication.
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Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care.
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Eksperymentalny: Aerobic Exercise
Participants will receive supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks, in addition to their usual antihypertensive medication.
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Participants will perform supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks in addition to usual medical care.
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Eksperymentalny: Smartphone-Guided Paced Breathing
Participants will receive smartphone-guided paced breathing training for 12 weeks, in addition to their usual antihypertensive medication.
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Participants will perform smartphone-guided paced breathing at approximately 6 breaths per minute according to the study protocol for 12 weeks in addition to usual medical care.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in resting systolic blood pressure (mmHg).
Ramy czasowe: Baseline and 12 weeks
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Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
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Baseline and 12 weeks
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Change in Diastolic Blood Pressure
Ramy czasowe: Baseline and 12 weeks
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Change in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
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Baseline and 12 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Resting Heart Rate
Ramy czasowe: Baseline and 12 weeks
|
Change in resting heart rate (beats per minute), measured after an appropriate resting period using standardized procedures.
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Baseline and 12 weeks
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Change in Functional Capacity
Ramy czasowe: Baseline and 12 weeks
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Functional capacity assessed by the 6-Minute Walk Test (6MWT).
The total distance walked in six minutes (meters) will be recorded according to the American Thoracic Society guidelines.
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Baseline and 12 weeks
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Change in Health-Related Quality of Life
Ramy czasowe: Baseline and 12 weeks
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Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).
The SF-12 generates two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Each summary score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
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Baseline and 12 weeks
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PTCU-HTN-2026-001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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