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.: PACTR201112000341237 Date of Approval: 24/11/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Exercise and Hypertension
Official scientific title EFFECTS OF PHYSICAL EXERCISE ON CARDIOVASCULAR PARAMETERS, CORONARY HEART DISEASE RISK FACTORS AND PSYCHOSOCIAL STATUS OF SUBJECTS WITH HYPERTENSION
Brief summary describing the background and objectives of the trial Studies have shown that exercise training lowers blood pressure in hypertensive patients; however, in most cases, exercise alone will not reduce high blood pressure to normal level. Exercise scientists and other health related professionals have used various training methods to evaluate theses physiological changes. Two of these methods of training are widely used and they are frequently labeled as continuous and interval exercise which consists of repeated series of exercise bouts with intervening rest periods. Although, there appears to be a general agreement regarding the fact that both continuous and interval training programmes can beneficially alter many physiological parameters, however, there is still controversy regarding the level and format of exercise that can yield optimal beneficial effects. Also, only a few studies have systematically attempted to determine which exercise programme optimally affects each of these variables in hypertensive patients, particularly in older individuals. The purpose of the study was to determine the effects of both continuous and interval training programmes on cardiovascular fitness/ parameters such as Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), VO2 max, selected CHD risk factors.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 13/06/2007
Actual trial start date 24/10/2007
Anticipated date of last follow up 01/01/2008
Actual Last follow-up date 15/02/2008
Anticipated target sample size (number of participants) 484
Actual target sample size (number of participants) 357
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 Age matched randomized - Subjects were arranged according to their age in ascending order and were allocated to the 3 (interval, continuous and control) groups in that ascending order. Blinding - From this age matched randomized method, the allocation has been automatically coded from the participants and person allocating; its the age in order that determine who fall in which group not the person allocating the participants. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Interval group 8week, 3 times per week for 45-60minutes Interval exercise 140
Experimental Group Continuous group 8week, 3 times per week 45-60minutes Continuous exercise 112
Control Group Control group 8week 8 weeks 0 105
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only those who volunteered to participate in the study were recruited. Subjects between the age range of 50 and 70 years with chronic mild to moderate and stable (> 1 year duration) hypertension (SBP between 140-179 & DBP between 90-109 mmHg) were selected. Only those who had stopped taking antihypertensive drugs or on a single antihypertensive medication (Methyldopa)were recruited. They were sedentary and have no history of psychiatry or psychological disorders or abnormalities. Obese or underweight (BMI between 20 & 30 kg/m2), smokers, alcoholic, diabetic, other cardiac, renal, respiratory disease patients (as reported in Appendix G and subjects¿ case file) were excluded. Those involved in vigorous physical activities and and above averagely physically fit (VO2max >27 & >33 ml/kg.min for over 60 & 50 years old respectively) were also excluded. 45 Year(s) 70 Year(s) Male
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 19/01/2007 Kano State Hospital Management Board, Kano, Nigeria
Ethics Committee Address
Street address City Postal code Country
Kano PMB 3540 Nigeria
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 28/11/2006 Faculty Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Health Sciences and Technology, University of Nigerian, Enugu Campus Enugu Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HR, SBP, DBP, VO2 max, % body fat, BMI, Waist/Hip ratio, TC, HDL-C, LDL-C, TG, AI, Na¿:K¿, HCO3-, FBS, WBC count, CRP, uric acid, creatinine and psychosocial status. 8weeks
Secondary Outcome HR, SBP, DBP, VO2 max, % body fat, BMI, Waist/Hip ratio, TC, HDL-C, LDL-C, TG, AI, Na¿:K¿, HCO3-, FBS, WBC count, CRP, uric acid, creatinine and psychosocial status. 8weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammed Specialist Hospital Hypertensive Clinic, Murtala Muhammed Specialist Hospital. Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self (Lamina Sikiru) Federal University of Technology, Owerri Owerri PMB 11526 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Lamina Sikiru Federal University of Technology, Owerri Owerri PMB 1526 Nigeria Funding Agency
Secondary Sponsor University of Nigeria, Enugu Campus Medical Rehabilitation Dept., Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus. Enugu Nigeria University
COLLABORATORS
Name Street address City Postal code Country
OKOYE GC Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sikiru Lamina siklam_86@yahoo.co.uk +2348035319469 Fedreal University of Technology, Owerri
City Postal code Country Position/Affiliation
Owerri PMB 1526 Nigeria
Role Name Email Phone Street address
Public Enquiries G.C. Professor G.C Okoye chubaokoye@yahoo.com +234-8183541830 Faculty of Health Science and Technology, University of Nigeria, Enugu Campus, Nigeria.
City Postal code Country Position/Affiliation
Enugu Nigeria Medical Rehabilitation Dept.,
Role Name Email Phone Street address
Scientific Enquiries Chuba G Okoye chubaokoye@yahoo.com +234-8183541830 University of University, Enugu Campus
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer
REPORTING
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Result URL Hyperlinks
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