Effect of Different Pranayama Breathing Techniques on Qua... | NCT05651854

Studies
Effect of Different Pranayama Breathing Techniques on Quality of Life in Hypertensive Patients

NCT05651854

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 22, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hypertension
Stress
Aging Problems

Interventions

pranayama breathing

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Feb 15, 2023Estimated

Completion Date

Feb 28, 2023Estimated

First Submitted Date

Dec 7, 2022

First Submission Date that Met QC Criteria

Dec 7, 2022

First Posted Date

Dec 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2023

Last Update Posted Date

Feb 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	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).	Other: pranayama breathing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pranayama breathing	Other	Bhramari and sheetali pranayama breathing	Bhramari pranayama breathing Sheetali pranayama breathing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cortisol	serum cortisol level	3 months

Secondary Outcomes

Measure	Description	Time Frame
Nitric oxide	serum nitric oxide	3 months
systolic blood pressure	systolic blood pressure	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
salma elsheikh, assistant lecturer	Contact	01118254965		selsheikh25@yahoo.com
Ali Esmail, lecturer	Contact	01005154209		ali.mohamed@pt.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Nesreen Elnahas, professor doctor	Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy	Recruiting	Dokki	Giza Governorate	12613	Egypt

ID	Term
D006973	Hypertension
D009043	Motor Activity

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001519	Behavior