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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shimaa Taha, PhD
- Numéro de téléphone: +201021088610
- E-mail: shimaa.taha@cu.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Mona Ziethar, Lecturer of Physical Therapy f
- Numéro de téléphone: +201151602624
- E-mail: monaamin028@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in resting systolic blood pressure (mmHg).
Délai: Baseline and 12 weeks
|
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
|
|
Change in Diastolic Blood Pressure
Délai: Baseline and 12 weeks
|
Change in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
|
Baseline and 12 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Resting Heart Rate
Délai: Baseline and 12 weeks
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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
Délai: Baseline and 12 weeks
|
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
Délai: Baseline and 12 weeks
|
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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PTCU-HTN-2026-001
Plan pour les données individuelles des participants (IPD)
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