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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
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.
Participants will perform supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks in addition to usual medical care.
Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care.
Change in resting systolic blood pressure (mmHg).
Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Time frame: Baseline and 12 weeks
Change in Diastolic Blood Pressure
Change in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Time frame: Baseline and 12 weeks
Change in Resting Heart Rate
Change in resting heart rate (beats per minute), measured after an appropriate resting period using standardized procedures.
Time frame: Baseline and 12 weeks
Change in Functional Capacity
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.
Time frame: Baseline and 12 weeks
Change in Health-Related Quality of Life
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.
Time frame: Baseline and 12 weeks
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