Stage 1 HypertensivesNCT07573683
Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals
A study testing Coherent Breathing. and Aerobic Exercises in people with Stage 1 Hypertensives, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Stage 1 Hypertensives
- What is being tested?
- Coherent Breathing. and Aerobic Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2026to 15 May 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female genders.
- Adults aged 30-65 years.
- Patients diagnosed with stage 1 hypertension 130-139/80-89mm Hg according to ACC/AHA 2017 guidelines.
- Mild to moderate physical activity level on IPAQ questionnaire.
- Individuals able to understand and follow the instructions.
Who cannot join
- Diagnosed uncontrolled hypertensive patients.
- Unstable angina, MI, heart failure, advanced CAD patients, COPD, Asthma.
- Severe neurological, musculoskeletal or gynecological conditions which limit participation in the study.
- Recent history of fracture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad
Syeda Sumaira Batool, MSPT-CPT, 03328868680, sumaira.batool@fui.edu.pk
About this study
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Participants will be randomly assigned to an intervention group (aerobic exercise plus coherent breathing) or a control group (aerobic exercise only) and will undergo a 4-week program with 5 sessions per week.
Cardiopulmonary parameters-including blood pressure, heart rate, respiratory rate, and rate pressure product-will be measured, and quality of life will be assessed using the MINICHAL questionnaire at baseline, 2 weeks, and post-intervention. Data will be analyzed using SPSS version 21.0.
The study aims to determine whether coherent breathing provides additional benefits, offering a cost-effective, non-pharmacological strategy for hypertension management in low-resource settings.
Read the detailed description
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. A normal reading is less than 120 millimeters of mercury over less than 80 millimeters of mercury. Hypertension is a prevalent condition affecting approximately 1.28 billion individuals globally, with a significant burden observed in low- and middle-income countries such as Pakistan. Stage 1 hypertension is defined by a systolic blood pressure (SBP) between 130-139 mmHg or diastolic blood pressure (DBP) between 80-89 mmHg. High blood pressure causes no signs or symptoms, which is why healthcare providers call it a "silent killer." Non-pharmacological interventions, including aerobic exercise and breathing techniques, have shown promise in improving cardiopulmonary function and quality of life.
Coherent breathing is a controlled breathing technique that involves inhaling and exhaling at a steady, slow pace-typically around five to six breaths per minute, with each inhale and exhale lasting about six seconds. This study aims to evaluate the additional effects of coherent breathing techniques when combined with aerobic exercise, compared to aerobic exercise alone. A randomized controlled trial design will be employed. The study will be conducted over a period of 1 year at Foundation University College of Physical Therapy and Fauji Foundation Hospital Rawalpindi. Ethical approval will be obtained from ERC FUMC and IRC, and the trial will be registered with CBRC and the clinical trial registry. Data will be analyzed using SPSS version 21.0.
This study will fill a critical gap in the literature by assessing the additive benefits of coherent breathing in hypertension management. The findings may support cost-effective, non-pharmacological strategies in low-resource settings, contributing to improved public health outcomes
- Conditions
- Stage 1 Hypertensives
- Being tested
- Coherent Breathing., Aerobic Exercises
- Keywords
- Stage 1 Hypertensives, Breathing, Aerobic Exercises, Cardiopulmonary parameters, Coherent breathing technique, Quality of life
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coherent Breathing.Other
Coherent breathing technique involve consciously reducing the breathing rate, typically to fewer than 10 breaths per minute, often around 6 breaths per minute. Coherent breathing is performed for 10 minutes.
Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a period of 30 min.
Aerobic ExercisesOther
Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercises | Active comparator | This Group performs aerobic exercises as follows:
Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk.
Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 40 minutes TYPE: Aerobic exercises \& simple breathing Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk.
Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing exercies for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 40 minutes TYPE: Aerobic exercises \& simple breathing. A total of 20 sessions Five days per week for 4 weeks. Receives: Other: Aerobic Exercises |
| Aerobic Exercises with coherent breathing | Experimental | This group performs aerobic exercises combined with coherent breathing technique.
Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk.
Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 30 minutes TYPE: Aerobic exercises. Coherent Breathing technique for 10 minutes. TOTAL DURATION: 40 minutes Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk.
Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 30 minutes TYPE: Aerobic exercises Receives: Other: Coherent Breathing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (beats per minute)
Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.
Measured: 04 weeks
Systolic Blood Pressure (mmHg)
Measured using standardized sphygmomanometer at baseline and post-intervention.
Measured: 04 weeks
Diastolic Blood Pressure (mmHg)
Measured using standardized sphygmomanometer at baseline and post-intervention.
Measured: 04 weeks
Peripheral Oxygen Saturation (SpO₂, %)
Measured using pulse oximeter under resting conditions at baseline and post-intervention.
Measured: 04 weeks
Respiratory Rate (breaths/minute)
Measured by direct observation at baseline and post-intervention.
Measured: 04 weeks
Rate Pressure Product (HR × SBP)
Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.
Measured: 04 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start28 Feb 2026
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 1 HypertensivesStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- This is a randomized controlled studies involving two groups. Control group will perform only aerobic exercises. Interventional group will perform both coherent breathing and aerobic exercises.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573683
- Sponsor's protocol ID
- FUCP/CTR/2026/06
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effect of Coherent Breathing With Aerobic Exercise on Cardiopulmonary Parameters and Quality of Life in Stage 1 Hypertensive Individuals
- ClinicalTrials.gov ID
- NCT07573683
- Acronym / sponsor ID
- FUCP/CTR/2026/06
- Conditions
- Stage 1 Hypertensives
- Keywords
- Stage 1 Hypertensives, Breathing, Aerobic Exercises, Cardiopulmonary parameters, Coherent breathing technique, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 7 May 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.
This study will use a randomized controlled trial to evaluate the added effects of coherent breathing combined with aerobic exercise versus aerobic exercise alone in 40 adults aged 30-65 with stage 1 hypertension. Participants will be randomly assigned to an intervention group (aerobic exercise plus coherent breathing) or a control group (aerobic exercise only) and will undergo a 4-week program with 5 sessions per week.
Cardiopulmonary parameters-including blood pressure, heart rate, respiratory rate, and rate pressure product-will be measured, and quality of life will be assessed using the MINICHAL questionnaire at baseline, 2 weeks, and post-intervention. Data will be analyzed using SPSS version 21.0.
The study aims to determine whether coherent breathing provides additional benefits, offering a cost-effective, non-pharmacological strategy for hypertension management in low-resource settings.
Detailed description
Hypertension, also known as high or raised blood pressure, is a condition in which the blood vessels have persistently raised pressure. A normal reading is less than 120 millimeters of mercury over less than 80 millimeters of mercury. Hypertension is a prevalent condition affecting approximately 1.28 billion individuals globally, with a significant burden observed in low- and middle-income countries such as Pakistan. Stage 1 hypertension is defined by a systolic blood pressure (SBP) between 130-139 mmHg or diastolic blood pressure (DBP) between 80-89 mmHg. High blood pressure causes no signs or symptoms, which is why healthcare providers call it a "silent killer." Non-pharmacological interventions, including aerobic exercise and breathing techniques, have shown promise in improving cardiopulmonary function and quality of life.
Coherent breathing is a controlled breathing technique that involves inhaling and exhaling at a steady, slow pace-typically around five to six breaths per minute, with each inhale and exhale lasting about six seconds. This study aims to evaluate the additional effects of coherent breathing techniques when combined with aerobic exercise, compared to aerobic exercise alone. A randomized controlled trial design will be employed. The study will be conducted over a period of 1 year at Foundation University College of Physical Therapy and Fauji Foundation Hospital Rawalpindi. Ethical approval will be obtained from ERC FUMC and IRC, and the trial will be registered with CBRC and the clinical trial registry. Data will be analyzed using SPSS version 21.0.
This study will fill a critical gap in the literature by assessing the additive benefits of coherent breathing in hypertension management. The findings may support cost-effective, non-pharmacological strategies in low-resource settings, contributing to improved public health outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled studies involving two groups. Control group will perform only aerobic exercises. Interventional group will perform both coherent breathing and aerobic exercises.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercises | Active comparator | Other: Aerobic ExercisesThis Group performs aerobic exercises as follows: Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 40 minutes TYPE: Aerobic exercises \& simple breathing Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform simple breathing exercies for 10 minutes. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 40 minutes TYPE: Aerobic exercises \& simple breathing. A total of 20 sessions Five days per week for 4 weeks. |
| Aerobic Exercises with coherent breathing | Experimental | Other: Coherent Breathing.This group performs aerobic exercises combined with coherent breathing technique. Week 1-2 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 50 - 60% THR TIME: 30 minutes TYPE: Aerobic exercises. Coherent Breathing technique for 10 minutes. TOTAL DURATION: 40 minutes Week 3-4 Warm up exercises for 5 minutes. Brisk walking on treadmill-for 15 minutes was included warm up period for 5 minutes then 9 minutes brisk walk and cool down period included 1 minute walk. Stepper for 2 minutes. Static cycling for 3 minutes. Cool down for 5 minutes. Perform coherent breathing technique for 10 min. FREQUENCY: 5 days / week INTENSITY: 60 - 80% THR TIME: 30 minutes TYPE: Aerobic exercises |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both male and female genders.
- Adults aged 30-65 years.
- Patients diagnosed with stage 1 hypertension 130-139/80-89mm Hg according to ACC/AHA 2017 guidelines.
- Mild to moderate physical activity level on IPAQ questionnaire.
- Individuals able to understand and follow the instructions.
Key exclusion criteria (4 listed)
- Diagnosed uncontrolled hypertensive patients.
- Unstable angina, MI, heart failure, advanced CAD patients, COPD, Asthma.
- Severe neurological, musculoskeletal or gynecological conditions which limit participation in the study.
- Recent history of fracture.
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 |
|---|---|---|
| Coherent Breathing.Coherent breathing technique involve consciously reducing the breathing rate, typically to fewer than 10 breaths per minute, often around 6 breaths per minute. Coherent breathing is performed for 10 minutes. Aerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a period of 30 min. | Other | Aerobic Exercises with coherent breathing |
| Aerobic ExercisesAerobic Exercises involving brisk walking, warm up, stepper, static cycling, cool down for a periof of 30 min. | Other | Aerobic Exercises |
Primary outcome
Heart Rate (beats per minute)
Time frame: 04 weeks
Measured using calibrated digital monitor after 5 minutes rest at baseline and post-intervention.
Systolic Blood Pressure (mmHg)
Time frame: 04 weeks
Measured using standardized sphygmomanometer at baseline and post-intervention.
Diastolic Blood Pressure (mmHg)
Time frame: 04 weeks
Measured using standardized sphygmomanometer at baseline and post-intervention.
Peripheral Oxygen Saturation (SpO₂, %)
Time frame: 04 weeks
Measured using pulse oximeter under resting conditions at baseline and post-intervention.
Respiratory Rate (breaths/minute)
Time frame: 04 weeks
Measured by direct observation at baseline and post-intervention.
Rate Pressure Product (HR × SBP)
Time frame: 04 weeks
Calculated from heart rate and systolic blood pressure at baseline and post-intervention as an index of myocardial workload.
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 7 May 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coherent Breathing. and Aerobic Exercises in people with Stage 1 Hypertensives, run by Foundation University Islamabad at 1 site in Pakistan.
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 4 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: looking for participants now, as of the sponsor's last update on 7 May 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 Pakistan. 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?
Contact Kainat Zahra, MSPT-CPPT (03367343005, zahrakainat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (beats per minute) (time frame: 04 weeks). The study lists 6 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 7 May 2026.