Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-50
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Aerobic Exercise

    Behavioral

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

  • 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.

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Combined InterventionExperimental treatment 1 intervention
Group B: Aerobic ExerciseExperimental treatment 1 intervention
Group C: Smartphone-Guided Paced BreathingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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