Essential (Primary) HypertensionSPB-HTNNCT07717996
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
A study testing Smartphone-Guided Paced Breathing, Aerobic Exercise and Smartphone-Guided Paced Breathing + Aerobic Exercise in people with Essential (Primary) Hypertension, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Essential (Primary) Hypertension
- What is being tested?
- Smartphone-Guided Paced Breathing, Aerobic Exercise and Smartphone-Guided Paced Breathing + Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy, Cairo university
Cairo, Cairo Governorate
About this study
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
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.
Read the 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.
- Conditions
- Essential (Primary) Hypertension
- Being tested
- Smartphone-Guided Paced Breathing, Aerobic Exercise, Smartphone-Guided Paced Breathing + Aerobic Exercise
- 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
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-Guided Paced BreathingBehavioural
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 ExerciseBehavioural
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 ExerciseBehavioural
Participants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Smartphone-Guided Paced Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting systolic blood pressure (mmHg).
Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Change in Resting Heart Rate
Change in resting heart rate (beats per minute), measured after an appropriate resting period using standardized procedures.
Measured: 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.
Measured: 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). 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start25 Jul 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential (Primary) HypertensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Taha Mohamed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717996
- Sponsor's protocol ID
- PTCU-HTN-2026-001
- Acronym
- SPB-HTN
- Status last verified
- Nov 2026
- First submitted
- 16 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07717996
- Acronym / sponsor ID
- SPB-HTN / PTCU-HTN-2026-001
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention | Experimental | Behavioral: Smartphone-Guided Paced Breathing + Aerobic ExerciseParticipants 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. |
| Aerobic Exercise | Experimental | Behavioral: Aerobic ExerciseParticipants will receive supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks, in addition to their usual antihypertensive medication. |
| Smartphone-Guided Paced Breathing | Experimental | Behavioral: Smartphone-Guided Paced BreathingParticipants will receive smartphone-guided paced breathing training for 12 weeks, in addition to their usual antihypertensive medication. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-Guided Paced BreathingParticipants 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. | Behavioural | Smartphone-Guided Paced Breathing |
| Aerobic ExerciseParticipants will perform supervised moderate-intensity aerobic exercise three sessions per week for 12 weeks in addition to usual medical care. | Behavioural | Aerobic Exercise |
| Smartphone-Guided Paced Breathing + Aerobic ExerciseParticipants will receive smartphone-guided paced breathing combined with supervised moderate-intensity aerobic exercise for 12 weeks in addition to usual medical care. | Behavioural | Combined Intervention |
Primary outcome
Change in resting systolic blood pressure (mmHg).
Time frame: Baseline and 12 weeks
Change in resting systolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
Change in Diastolic Blood Pressure
Time frame: Baseline and 12 weeks
Change in resting diastolic blood pressure (mmHg), measured using a validated automated sphygmomanometer according to standardized procedures.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-Guided Paced Breathing, Aerobic Exercise and Smartphone-Guided Paced Breathing + Aerobic Exercise in people with Essential (Primary) Hypertension, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting systolic blood pressure (mmHg). (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.