Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension

NCT07717996 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2026-07-25

Last updated

2026-11-03

Condition(s) studied

Essential (Primary) Hypertension

Investigational drug(s) / intervention(s)

Smartphone-Guided Paced BreathingAerobic ExerciseSmartphone-Guided Paced Breathing + Aerobic Exercise

Smartphone-Guided Paced Breathing: 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.

Aerobic Exercise: Participants will perform supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks in addition to usual medical care.

Smartphone-Guided Paced Breathing + Aerobic Exercise: Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care.

Study summary

Hypertension is a major risk factor for cardiovascular disease and is associated with reduced functional capacity and impaired quality of life. Non-pharmacological interventions, including aerobic exercise and paced breathing, may improve blood pressure control by enhancing cardiovascular and autonomic function. This randomized controlled trial will evaluate whether combining smartphone-guided paced breathing with aerobic exercise provides greater benefits than either intervention alone in adults with essential hypertension. Seventy-five participants will be randomly assigned to one of three groups: (1) smartphone-guided paced breathing combined with aerobic exercise, (2) aerobic exercise alone, or (3) smartphone-guided paced breathing alone. The intervention will last 12 weeks. The primary outcome measures are systolic and diastolic blood pressure. Secondary outcome measures include heart rate, functional capacity assessed by the 6-Minute Walk Test, and health-related quality of life assessed using the Short Form-12 (SF-12) questionnaire. The findings of this study may help identify an effective, accessible, and low-cost non-pharmacological strategy for improving cardiovascular health and quality of life in patients with essential hypertension.

Eligibility

Sex

ALL

Min age

40 Years

Max age

50 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change in resting systolic blood pressure (mmHg). — Baseline and 12 weeks
Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Change in Diastolic Blood Pressure — Baseline and 12 weeks
Change in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.

Trial sites (1)

Facility	City	Region	Status
Faculty of physical therapy, Cairo university	Cairo	Cairo Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07717996 on ClinicalTrials.gov ↗ ← All trials in Egypt