- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05651854
Effect of Different Pranayama Breathing Techniques on Quality of Life in Hypertensive Patients
Effect of Bhramari Versus Sheetali Pranayama on Quality of Life in Hypertensive Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: salma elsheikh, assistant lecturer
- Phone Number: 01118254965
- Email: selsheikh25@yahoo.com
Study Contact Backup
- Name: Ali Esmail, lecturer
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Locations
-
-
Giza
-
Dokki, Giza, Egypt, 12613
- Recruiting
- Faculty of Physical Therapy
-
Contact:
- Salma Elsheikh
- Email: selsheikh25@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bhramari pranayama breathing
Bhrāmarī Prāṇāyāma breathing involves inhalation through both nostrils and producing humming sound of a bee while exhaling (Nivethitha et al., 2016).
|
Bhramari and sheetali pranayama breathing
|
|
Experimental: Sheetali pranayama breathing
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).
|
Bhramari and sheetali pranayama breathing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cortisol
Time Frame: 3 months
|
serum cortisol level
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nitric oxide
Time Frame: 3 months
|
serum nitric oxide
|
3 months
|
|
systolic blood pressure
Time Frame: 3 months
|
systolic blood pressure
|
3 months
|
|
diastolic blood pressure
Time Frame: 3 months
|
diastolic blood pressure
|
3 months
|
|
30 seconds sit to stand test
Time Frame: 3 months
|
physical fitness assessment
|
3 months
|
|
SF12 quality of life questionnaire
Time Frame: 3 months
|
quality of life questionnaire
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nesreen Elnahas, professor doctor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pranayama on hypertension
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.