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.: PACTR202408801019566 Date of Approval: 08/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Total Body Vibration Exercises versus Aerobic Exercises on Left Ventricular Diameter in Hypertensive Elderly
Official scientific title Total Body Vibration Exercises versus Aerobic Exercises on Left Ventricular Diameter in Hypertensive Elderly
Brief summary describing the background and objectives of the trial Vascular aging is accelerated by coexisting cardiovascular risk factors, such as hypertension, metabolic syndrome and diabetes. The beneficial effect of physical activity on cardiovascular health is well-established ethier with regular aerobic exercise and endurance training or with mechanical stimulation. so the main aim of the study is to compare the effect of whole body vibration vs aerobic exercise on left ventricular diameter in hypertensive elderly.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 14/08/2024
Actual trial start date 14/08/2024
Anticipated date of last follow up 14/11/2024
Actual Last follow-up date 14/11/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group whole body vibration exercise with medication Three sessions per week for 12 weeks 20 minutes All subjects will take stable (> 1 year) antihypertensive medication(s) at time of enrollment and continue the treatment throughout the study period (ANGIOTENSIN CONVERTING ENZYME INHIBITORS (ACEIs) ACEIs for 2.5 mg PO once daily under supervision of internal medicine specialist and according to the patient needs ). After warming up period of 10 to 15 minutes, each participant stands on the vibrator platform with bare feet and hand besides the body for 20 minutes using frequency of 30 Hz and amplitude of 2 mm. 20
Experimental Group Aerobic exercises with medication 3 sessions per week 3 sessions per week for 12 weeks All subjects will take stable (> 1 year) antihypertensive medication(s) at time of enrollment and continue the treatment throughout the study period (ANGIOTENSIN CONVERTING ENZYME INHIBITORS (ACEIs) ACEIs for 2.5 mg PO once daily under supervision of internal medicine specialist and according to the patient needs), in addition aerobic exercise after warming up period for 10-15 minutes. Aerobic exercise on treadmill machine for 20 minutes. 20
Control Group stable antihypertensive medication NGIOTENSIN CONVERTING ENZYME INHIBITORS (ACEIs) ACEIs for 2.5 mg PO once daily under supervision of internal medicine specialist and according to the patient needs at time of enrollment and continue the treatment throughout the study period the participants in the control group will receive the medication only under the supervision of internal medicine specialist 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Patients should have • Hypertension as will diagnose by physicians. Systolic blood pressure(140-160) mmHg and Diastolic blood pressure(90-100) mmHg • All subjects will take stable (> 1 year) antihypertensive medication(s) at time of enrollment and continue the treatment throughout the study period. • Body mass index for patients will be ranged from (30 to 34.9) BMI class I obesity. • The test will be conducted on the patient in two hours postprandial state only. • Non smoker • Sedentary < 90 min of regular exercise per week. If they have any of the following diseases will not be included in this study as:- • Diabetic neuropathy disease • Hepatic diseases. • Unstable Cardiovascular and pulmonary disease • Cancer diseases. • Renal failure disease. • Recent surgery. Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 65 Year(s) Both
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 05/03/2024 Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Ben Elsarayte, Giza, Egypt Giza 123414 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Left Ventricular end Diastolic Diameter LVEDD (mm) before and after 12 weeks of training
Primary Outcome Left Ventricular End-Systolic diameter LVESD (mm) before and after 12 week of training
Secondary Outcome low density lipoprotein LDL, High density lipoprotein HDL, Cholesterol , before and after 12 week of training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElMataria Teaching hospital Mataria, Cairo, Egypt Cairo 343534 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self fund Ben elsarayate, Giza, Egypt Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self Ben Elsarayate, Giza, Egypt Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gihan Mousa Gihanmousa79@gmail.com 00966564993236 Giza, Egypt
City Postal code Country Position/Affiliation
Giza Egypt Faculty of Physical Therapy Cairo University Egypt.
Role Name Email Phone Street address
Public Enquiries Heba Bahey ElDeen hbahey@ju.edu.sa 00201155925552 Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of physical therapy Must University
Role Name Email Phone Street address
Scientific Enquiries Mariam Ameer mariam.abdelmonim@cu.edu.eg 00201061273399 Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes - The individual participant data will be available, - The data will include Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures), - The study protocol will also be available. - The data will be available Immediately following publication, No end date - Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose Informed Consent Form,Statistical Analysis Plan,Study Protocol after publication the access will be controlled with the committee the give the approval of this study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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