HypertensionNCT05651854
Effect of Different Pranayama Breathing Techniques on Quality of Life in Hypertensive Patients
A study testing pranayama breathing in people with Hypertension and Stress, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the current study is to compare between the effect of Bhramari pranayama versus Sheetali pranayama on quality of life in hypertensive patients. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hypertension, Stress, Aging Problems
- What is being tested?
- pranayama breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty elderly are selected from both sexes. 2-Their age ranges from 60-75 years old. 3-Hypertensive patients (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).
- 4-Their body mass index (BMI) ranged from < 30kg/m2. 5-All patients are medically stable.
Who cannot join
- - patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, Recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.
- 2- Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
- 3-Patients who have difficulty in rolling the tongue for Sheetali practice as stroke or Bell's palsy.
- 4- Tongue swelling in case of acromegaly, amyloidosis, Myxedema and tongue cancer.
- 5- Tongue pain in case of diabetic neuropathy, mouth ulcers, oral cancer and burn in the mouth.
- 6- Chronic smokers and alcoholics. 7- Severe ear infections that interfere with bhramari breathing.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Dokki, Giza Governorate, 12613
Salma Elsheikh, selsheikh25@yahoo.com
About this study
Official title: Effect of Bhramari Versus Sheetali Pranayama on Quality of Life in Hypertensive Patients
The purpose of the current study is to compare between the effect of Bhramari pranayama versus Sheetali pranayama on quality of life in hypertensive patients.
Read the detailed description
People with hypertension have poorer sleep quality, less physical activity and more psychological stress than those with normal blood pressure. It has been shown that sleep affects vitality and health status and that sleep problems affect daily functioning and QOL, and so it can be assumed that in patients with hypertension, sleep problems will have a negative effect on QOL (Uchmanowicz et al., 2019).
Yogic breathing exercises are known as Pranayamas and are considered a form of meditation in itself, as well as a preparation for deep meditation. They promote physical well-being and self-awareness, improve lung and cognitive capacities, reduce blood pressure, anxiety, and other psychosomatic patterns, probably by increasing the parasympathetic tone. Pranayama alone has demonstrated numerous beneficial health effects, including stress relief, beneficial cardiovascular effect, improved respiratory function, and enhanced cognition (Jayawardena et al.,2020 ).
Since there is no study examined effect of Bhramari versus Sheetali on quality of life, physical fitness and stress in hypertensive elderly, this study aimed to examine this comparison.
- Conditions
- Hypertension, Stress, Aging Problems
- Being tested
- pranayama breathing
- Keywords
- pranayama, quality of life, blood pressure, physical activity
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pranayama breathingOther
Bhramari and sheetali pranayama breathing
| Study group | Role | What they receive |
|---|---|---|
| Bhramari pranayama breathing | Experimental | Bhrāmarī Prāṇāyāma breathing involves inhalation through both nostrils and producing humming sound of a bee while exhaling (Nivethitha et al., 2016). Receives: Other: pranayama breathing |
| Sheetali pranayama breathing | Experimental | Sheetali pranayama involve inhalation through extension of the tongue outside the mouth and roll the sides of the tongue up so that it would form a tube. At the end of inhalation, the tongue is drawn in, mouth is closed and exhale through the nose (Thanalakshmi et al., 2014). Receives: Other: pranayama breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
cortisol
serum cortisol level
Measured: 3 months
Secondary outcomes (5)
Nitric oxide
serum nitric oxide
Measured: 3 months
systolic blood pressure
systolic blood pressure
Measured: 3 months
diastolic blood pressure
diastolic blood pressure
Measured: 3 months
30 seconds sit to stand test
physical fitness assessment
Measured: 3 months
SF12 quality of life questionnaire
quality of life questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Sep 2022
- Primary completion15 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Elsayed Mohammed Elsheikh, Cairo University
- Investigators
- Nesreen Elnahas, professor doctor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651854
- Sponsor's protocol ID
- Pranayama on hypertension
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 22 Feb 2023
- 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bhramari Versus Sheetali Pranayama on Quality of Life in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT05651854
- Acronym / sponsor ID
- Pranayama on hypertension
- Conditions
- Hypertension, Stress, Aging Problems
- Keywords
- pranayama, quality of life, blood pressure, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 15 Dec 2022 (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.
The purpose of the current study is to compare between the effect of Bhramari pranayama versus Sheetali pranayama on quality of life in hypertensive patients.
Detailed description
People with hypertension have poorer sleep quality, less physical activity and more psychological stress than those with normal blood pressure. It has been shown that sleep affects vitality and health status and that sleep problems affect daily functioning and QOL, and so it can be assumed that in patients with hypertension, sleep problems will have a negative effect on QOL (Uchmanowicz et al., 2019).
Yogic breathing exercises are known as Pranayamas and are considered a form of meditation in itself, as well as a preparation for deep meditation. They promote physical well-being and self-awareness, improve lung and cognitive capacities, reduce blood pressure, anxiety, and other psychosomatic patterns, probably by increasing the parasympathetic tone. Pranayama alone has demonstrated numerous beneficial health effects, including stress relief, beneficial cardiovascular effect, improved respiratory function, and enhanced cognition (Jayawardena et al.,2020 ).
Since there is no study examined effect of Bhramari versus Sheetali on quality of life, physical fitness and stress in hypertensive elderly, this study aimed to examine this comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bhramari pranayama breathing | Experimental | Other: pranayama breathingBhrāmarī Prāṇāyāma breathing involves inhalation through both nostrils and producing humming sound of a bee while exhaling (Nivethitha et al., 2016). |
| Sheetali pranayama breathing | Experimental | Other: pranayama breathingSheetali pranayama involve inhalation through extension of the tongue outside the mouth and roll the sides of the tongue up so that it would form a tube. At the end of inhalation, the tongue is drawn in, mouth is closed and exhale through the nose (Thanalakshmi et al., 2014). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sixty elderly are selected from both sexes. 2-Their age ranges from 60-75 years old. 3-Hypertensive patients (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).
- 4-Their body mass index (BMI) ranged from < 30kg/m2. 5-All patients are medically stable.
Key exclusion criteria (6 listed)
- - patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, Recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.
- 2- Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
- 3-Patients who have difficulty in rolling the tongue for Sheetali practice as stroke or Bell's palsy.
- 4- Tongue swelling in case of acromegaly, amyloidosis, Myxedema and tongue cancer.
- 5- Tongue pain in case of diabetic neuropathy, mouth ulcers, oral cancer and burn in the mouth.
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 |
|---|---|---|
| pranayama breathingBhramari and sheetali pranayama breathing | Other | Bhramari pranayama breathing, Sheetali pranayama breathing |
Primary outcome
cortisol
Time frame: 3 months
serum cortisol level
5 secondary outcomes
Nitric oxide
Time frame: 3 months
systolic blood pressure
Time frame: 3 months
diastolic blood pressure
Time frame: 3 months
30 seconds sit to stand test
Time frame: 3 months
SF12 quality of life questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
Nesreen Elnahas, professor doctor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pranayama breathing in people with Hypertension and Stress, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salma elsheikh, assistant lecturer (01118254965, selsheikh25@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol (time frame: 3 months). 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 22 Feb 2023.