Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension

Official title

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

Overview

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

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

Primary outcome measures

• Change in resting systolic blood pressure (mmHg). [Time frame: Baseline and 12 weeks]
• Change in Diastolic Blood Pressure [Time frame: Baseline and 12 weeks]

Secondary outcome measures (3)

• Change in Resting Heart Rate [Time frame: Baseline and 12 weeks]
• Change in Functional Capacity [Time frame: Baseline and 12 weeks]
• Change in Health-Related Quality of Life [Time frame: Baseline and 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07717996 · PTCU-HTN-2026-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗