Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension

NCT07717996 | Not Yet Recruiting DMC

• 1 other identifier: PTCU-HTN-2026-001
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Resting Heart Rate

  Baseline and 12 weeks

• Change in Functional Capacity

  Baseline and 12 weeks

• Change in Health-Related Quality of Life

  Baseline and 12 weeks

Study Arms (3)

Combined Intervention

EXPERIMENTAL

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

Aerobic Exercise

EXPERIMENTAL

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

Smartphone-Guided Paced Breathing

EXPERIMENTAL

Participants will receive smartphone-guided paced breathing training for 12 weeks, in addition to their usual antihypertensive medication.

Behavioral: Smartphone-Guided Paced Breathing

Interventions

Aerobic Exercise BEHAVIORAL

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

Aerobic Exercise

Smartphone-Guided Paced Breathing + Aerobic Exercise BEHAVIORAL

Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care.

Combined Intervention

Smartphone-Guided Paced Breathing BEHAVIORAL

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.

Smartphone-Guided Paced Breathing

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Essential Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Shimaa Taha, PhD

CONTACT

+201021088610; shimaa.taha@cu.edu.eg

Mona Ziethar, Lecturer of Physical Therapy f

CONTACT

+201151602624; monaamin028@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiovascular &Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07