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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Essential (Primary) Hypertension
• Intervention / Treatment: Behavioral: Smartphone-Guided Paced Breathing + Aerobic Exercise; Behavioral: Aerobic Exercise; Behavioral: Smartphone-Guided Paced Breathing

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shimaa Taha, PhD; Phone Number: +201021088610; Email: shimaa.taha@cu.edu.eg
• Study Contact Backup: Name: Mona Ziethar, Lecturer of Physical Therapy f; Phone Number: +201151602624; Email: monaamin028@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Adults aged 40-50 years. 2. Both males and females will be included. 3. Clinically diagnosed with essential (primary) hypertension confirmed by a physician.

  4. Stage 1-2 hypertension (SBP 130-160 mmHg and/or DBP 80-100 mmHg) based on standardized clinical measurement.

  5. Duration of diagnosed hypertension between 6 months and 5 years. 6. Stable on antihypertensive medication for at least 4 weeks prior to enrollment, with no planned medication changes.

  7. Medically stable and cleared for moderate-intensity exercise participation. 8. Able to understand instructions and independently perform smartphone-guided breathing exercises.

  9. Willing to participate and provide written informed consent.

Exclusion Criteria:

• 1. Secondary hypertension (renal, endocrine, or medication-induced hypertension).

  2. Severe or uncontrolled hypertension (SBP >180 mmHg and/or DBP >110 mmHg). 3. History of major cardiovascular events (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled arrhythmias, or decompensated heart failure).

  4. Chronic respiratory diseases affecting exercise tolerance (e.g., COPD, severe asthma).

  5. Neurological, musculoskeletal, or orthopedic conditions limiting safe participation in walking or exercise training.

  6. Cognitive impairment or psychiatric disorders affect comprehension or adherence.

  7. Participation in structured exercise or pulmonary rehabilitation programs within the last 3 months.

  8. Heavy Smoking 9. Pregnancy or lactation. 10. Any contraindications to exercise testing or training as defined by American College of Sports Medicine (ACSM) guidelines.

  11. Anticipated changes in antihypertensive medication during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Experimental: Aerobic Exercise; Participants will receive supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks, in addition to their usual antihypertensive medication.	Behavioral: Aerobic Exercise; Participants will perform supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks in addition to usual medical care.
Experimental: Smartphone-Guided Paced Breathing; Participants will receive smartphone-guided paced breathing training for 12 weeks, in addition to their usual antihypertensive medication.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resting systolic blood pressure (mmHg).	Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.	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.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Resting Heart Rate	Change in resting heart rate (beats per minute), measured after an appropriate resting period using standardized procedures.	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.	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). Higher scores indicate better health-related quality of life.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Mobile Health; Physical Therapy; Randomized Controlled Trial; Aerobic Exercise; Blood Pressure; Six-Minute Walk Test; Essential Hypertension; Functional Capacity; SF-12; Smartphone-Guided Paced Breathing; Nonpharmacological Treatment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: PTCU-HTN-2026-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No