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Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension

Effect of Smartphone-Guided Paced Breathing Combined With Aerobic Exercise on Blood Pressure, Functional Capacity, and Quality of Life in Patients With Essential Hypertension

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717996
Acronym
SPB-HTN
Enrollment
75
Registered
2026-07-21
Start date
2026-07-25
Completion date
2026-12-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential (Primary) Hypertension

Keywords

Essential Hypertension, Aerobic Exercise, Smartphone-Guided Paced Breathing, Physical Therapy, Blood Pressure, Functional Capacity, Six-Minute Walk Test, Quality of Life, SF-12, Mobile Health, Nonpharmacological Treatment, Randomized Controlled Trial

Brief 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.

Detailed description

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.

Interventions

BEHAVIORALSmartphone-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.

BEHAVIORALAerobic Exercise

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

BEHAVIORALSmartphone-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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Outcome assessments will be performed by an assessor who is blinded to group allocation. Participants and treating therapists cannot be blinded because of the nature of the interventions.

Intervention model description

Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel intervention groups: (1) smartphone-guided paced breathing combined with aerobic exercise, (2) aerobic exercise alone, or (3) smartphone-guided paced breathing alone. Each participant will receive only the assigned intervention throughout the 12-week study period.

Eligibility

Sex/Gender
ALL
Age
40 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in resting systolic blood pressure (mmHg).Baseline and 12 weeksChange in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Change in Diastolic Blood PressureBaseline and 12 weeksChange in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.

Secondary

MeasureTime frameDescription
Change in Resting Heart RateBaseline and 12 weeksChange in resting heart rate (beats per minute), measured after an appropriate resting period using standardized procedures.
Change in Functional CapacityBaseline and 12 weeksFunctional 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.
Change in Health-Related Quality of LifeBaseline and 12 weeksHealth-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.

Contacts

CONTACTShimaa Taha, PhD
shimaa.taha@cu.edu.eg+201021088610
CONTACTMona Ziethar, Lecturer of Physical Therapy f
monaamin028@gmail.com+201151602624

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026