NCT05651854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 22, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

December 7, 2022

Last Update Submit

February 20, 2023

Conditions

Keywords

pranayamaquality of lifeblood pressurephysical activity

Outcome Measures

Primary Outcomes (1)

  • cortisol

    serum cortisol level

    3 months

Secondary Outcomes (5)

  • Nitric oxide

    3 months

  • systolic blood pressure

    3 months

  • diastolic blood pressure

    3 months

  • 30 seconds sit to stand test

    3 months

  • SF12 quality of life questionnaire

    3 months

Study Arms (2)

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

Bhramari and sheetali pranayama breathing

Bhramari pranayama breathingSheetali pranayama breathing

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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).
  • Their body mass index (BMI) ranged from \< 30kg/m2. 5-All patients are medically stable.

You may not qualify if:

  • \- 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.
  • Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.
  • Patients who have difficulty in rolling the tongue for Sheetali practice as stroke or Bell's palsy.
  • Tongue swelling in case of acromegaly, amyloidosis, Myxedema and tongue cancer.
  • Tongue pain in case of diabetic neuropathy, mouth ulcers, oral cancer and burn in the mouth.
  • Chronic smokers and alcoholics. 7- Severe ear infections that interfere with bhramari breathing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Dokki, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

HypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Nesreen Elnahas, professor doctor

    Cairo University

    STUDY CHAIR

Central Study Contacts

salma elsheikh, assistant lecturer

CONTACT

Ali Esmail, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patients are assigned randomly in groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
7 ahmed elzayyat st, Dokki, Giza, Egypt.

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

September 1, 2022

Primary Completion

February 15, 2023

Study Completion

February 28, 2023

Last Updated

February 22, 2023

Record last verified: 2022-12

Locations