Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202207676593752 Date of Approval: 18/07/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Breathing Exercise with Biofeedback on Blood Pressure in Pre hypertensive Women
Official scientific title Effect of Breathing Exercise with Biofeedback on Blood Pressure in Pre hypertensive Women
Brief summary describing the background and objectives of the trial This study will be an attempt to determine the relation between breathing exercise and biofeedback on BP in pre-hypertensive middle age women, which will be of valuable benefit for medical services organization and increase body of knowledge of physical therapist in scientific field.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PHT
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations,Obstetrics and Gynecology,Respiratory
Sub-Disease(s) or condition(s) being studied Fertility-female,Prehypertension
Purpose of the trial Treatment: Devices
Anticipated trial start date 05/06/2022
Actual trial start date 07/06/2022
Anticipated date of last follow up 01/08/2022
Actual Last follow-up date 06/08/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL no
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Effect of Breathing Exercise with Biofeedback on Blood Pressure in Pre hypertensive Women 3 days/ week 10 sessions They will receive slow abdominal breathing (six cycles/min) combined with frontal electromyography (EMG) biofeedback training. 15
Control Group Effect of breathing exercise on blood pressure in prehypertension women 3 days/ week 10 sessions They will perform slow abdominal breathing (six cycles/min) (3 days per week for 10 sessions). 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Their ages will range from 30-40years. All women will be diagnosed with pre-hypertension by digital sphygmomanometer (120 to 139 mm Hg for systolic Blood pressure and 80 to 89 mm Hg for diastolic blood pressure). Their BMI will be less than 30kg/m². Using any hypertension drugs during the month prior to initiation of the experiment. Cardiovascular, cerebrovascular, respiratory diseases, autoimmune diseases, diabetes, neuropathy and other autonomic neuropathies. Practicing any kind of relaxation technique. Adult: 19 Year-44 Year 30 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/04/2022 Faculty of Physical Therapy
Ethics Committee Address
Street address City Postal code Country
Street between chateaux / University of Cairo / Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This study will be an attempt to determine the relation between breathing exercise and biofeedback on blood pressure in pre-hypertensive middle age women, which will be of valuable benefit for medical services organization and increase body of knowledge of physical therapist in scientific field. Blood pressure
Secondary Outcome The relation between breathing exercise and biofeedback on heart rate variability ,skin galvanic response and respiratory rate in pre-hypertensive middle age women. Heart rate variability , skin galvanic response, respiratory rate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University Street between chateaux/ university of Cairo / Giza Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reham salah Madinaty Cairo 19519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Giza Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. DR. SOHIER MAHMOUD EL KOSIRY Street between chateaux / University of Cairo / Giza Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Reham Salah reeham_reka@yahoo.com 01005336583 madinaty b111 building 68
City Postal code Country Position/Affiliation
new cairo 19519 Egypt new cairo
Role Name Email Phone Street address
Public Enquiries Reham salah rehamsalah184@gmail.com 01113208323 madinaty
City Postal code Country Position/Affiliation
new cairo 19519 Egypt new cairo
Role Name Email Phone Street address
Principal Investigator Reham salah reham_reka@yahoo.com 01005336583 madinaty
City Postal code Country Position/Affiliation
Newcairo 19519 Egypt New Cairo
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in prehypertension. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by- case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to request, please contact.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Cairo university faculty of physical therapy No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information