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.: PACTR201902490588010 Date of Approval: 08/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Moderate Intensity Endurance Exercise on Responses of Relative Cardiovascular Parameters of Primary and Secondary Hypertensive Patients.
Official scientific title Moderate Intensity Endurance Exercise on Responses of Relative Cardiovascular Parameters of Primary and Secondary Hypertensive Patients.
Brief summary describing the background and objectives of the trial Hypertension (HTN), one of the most common medical disorders, is associated with an increased incidence of all-cause and cardiovascular disease (CVD) mortality. Lifestyle modifications are advocated for the prevention, treatment, and control of HTN, with exercise being an integral component. Exercise programs that primarily involve endurance activity prevent the development of HTN and lower blood pressure (BP) in adults with normal BP and those with HTN. The BP-lowering effects of exercise are most pronounced in people with HTN who engage in endurance exercise with BP decreasing approximately 5–7mm Hg after an isolated exercise session (acute) or following exercise training (chronic). Moreover, BP is reduced for up to 22 h after an endurance exercise bout (e.g., postexercise hypotension), with the greatest decreases among those with the highest baseline BP. The aim of this research is to compare the effectiveness of moderate-intensity aerobic exercise on relative cardiovascular parameters of primary and secondary hypertensive patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/02/2019
Actual trial start date 23/02/2019
Anticipated date of last follow up 23/03/2019
Actual Last follow-up date 06/04/2019
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 80
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Aerobic exercise Participants of this group will be individuals with primary hypertension, they will undergo aerobic exercises using cycle ergometer 3 times a week for 6 weeks The duration of the intervention will be 30 minutes per session. The participant will be instructed to sit on the seat of stationary Tunturi E6 Heart Control Ergometer (TUNTURI, USA) with both feet placed on the pedals and held in place with rubber straps. This exercise will be divided into 3 phases; the warm-up phase, an exercise phase, and a cool down phase. During the warm-up phase, the participant will pedal the bicycle for 5 minutes without any resistance, followed by the exercise phase during which the participant will pedal with low resistance. The resistance will gradually increase till the desired intensity of 50% maximum heart rate (MHR) is attained using estimated maximal heart rate (maximal heart rate=220 − age) for the first 6weeks. The exercise phase will last for 20 minutes and then follow by a cool down in which the participant will cycle resistance free for 5minutes. 20
Experimental Group Aerobic exercise group of patients with secondary hypertension The participants of this group will undergo aerobic exercise 3 times a week for 6weeks. The duration of the intervention will be 30minutes per session. The aerobic exercise participant will be instructed to sit on the seat of stationary Tunturi E6 Heart Control Ergometer (TUNTURI, USA) with both feet placed on the pedals and held in place with rubber straps. This exercise will be divided into 3 phases; the warm-up phase, an exercise phase, and a cool down phase. During the warm-up phase, the participant will pedal the bicycle for 5 minutes without any resistance, followed by the exercise phase during which the participant will pedal with low resistance. The resistance will gradually increase till the desired intensity of 50% maximum heart rate (MHR) is attained using estimated maximal heart rate (maximal heart rate=220 − age) for the first 6weeks. The exercise phase will last for 20 minutes and then follow by a cool down in which the participant will cycle resistance free for 5minutes 20
Control Group The routine care Primary hypertension control group Once a week. 30minutes The control group will be given health magazines to read and a lecture about the complication of High blood pressure, whereas the exercise groups will be engaged in the exercise programs. 20 Placebo
Control Group The routine care secondary hypertension control group Once a week. 30minutes per session The control group will be given health magazines to read and receive a lecture on the prevention of the complication of High blood pressure whereas the exercise groups will be engaged in the exercise programs. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i) Individuals diagnosed with primary or secondary hypertension ii) Male and female iii) Must be between 20 and 55 years of age. iv) Individuals who signed informed consent to participate in the study (i) Individuals with central nervous system dysfunction. (ii) Individuals with hemiparesis. (iii) Individuals with myelopathy. (iv) Individuals with limb amputation. (v) Individuals with scoliosis and inability to move ankle and knee joints actively. (vi) Individuals with severe Pain intensity or foot ulcer that cause limited standing. (vii) Individuals who are participating in other exercise programs. (viii) Individuals with a history of coronary artery disease, retinopathy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 55 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 07/01/2019 Kano State Hospital management Board ethical commutee
Ethics Committee Address
Street address City Postal code Country
Post office road kano. kano 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Systolic blood pressure, diastolic blood pressure, heart rate, rate pressure product pre -test 3weeks and 6weeks post intervention
Secondary Outcome maximum oxygen consumption, quality of life pre -test 3weeks and 6weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed specilaist Hospital Kano kano old city road. Kano 00234 Nigeria
Sheik Mohammed Jidda Hospital kano Abubakar rimi market road Kano 00234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdulsalam Mohammed Yakasai Reservoir hill west Vill campus Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UNIVERSITY OF KWAZULU NATAL RESERVOUR HILLS WESTVILL CAMPUS DURBAN 4000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. Sonill Maharaj Reservoir hills Durban 4000 South Africa
Dr. Abdullahi Ahmad Post office road Kano 00234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +2348060840806 5 NATHSON CLOSE OFF VARSITY DRIVE
City Postal code Country Position/Affiliation
DURBAN 4000 South Africa POSTDOCTORAL FELLOW
Role Name Email Phone Street address
Public Enquiries ABDULLAHI ABUBAKAR drabdul60@yahoo.com +2348054444447 Post office road
City Postal code Country Position/Affiliation
Kano 00234 Nigeria Head of Research ethical commitee
Role Name Email Phone Street address
Scientific Enquiries SONILL MAHARAJ ssmaharaj@ukzn.ac.za +27834611413 reservoir hill
City Postal code Country Position/Affiliation
DURBAN 4000 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I'm ready to share a summary of the outcome of the study. Clinical Study Report,Informed Consent Form,Study Protocol I shall share what I mentioned above as soon as we are done with data analysis and report (10 weeks) and it will be available for the period of 5years. The result of the outcomes will be available for everyone but the data collected in this study will be given to professionals on request.
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