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: www.pactr.org Trial no.: PACTR201112000341237 Date registered: 2011/11/24 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 Purpose of the trial Treatment Anticipated trial start date 2007-06-13 Actual trial start date 2007-10-24 Anticipated date of last follow up 2008-01-01 Actual date of last follow up 2008-02-15 Anticipated target sample size (number of participants) 484    Actual target sample size (number of participants) 357    Recruitment status Completed: recruitment & data analysis complete Secondary Ids Issuing authority/Trial register Links to Secondary ID 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 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 Min age Max 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 Years 70 Years 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 2006/11/28 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 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 2007/01/19 Kano State Hospital Management Board, Kano, Nigeria Ethics Committee Address Street address City Postal code Country Kano PMB 3540 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 Secondary Sponsor University of Nigeria, Enugu Campus Medical Rehabilitation Dept., Faculty of Health Sciences and Technology, University of Nigeria, Enugu Campus. Enugu Nigeria University Primary Sponsor Lamina Sikiru Federal University of Technology, Owerri Owerri PMB 1526 Nigeria Funding Agency 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 Fax Principal Investigator Dr Sikiru Lamina siklam_86@yahoo.co.uk +2348035319469 Street address City Postal code Country Position / Affiliation Fedreal University of Technology, Owerri Owerri PMB 1526 Nigeria Role Name Email Phone Fax Public Enquiries Prof G.C. Professor G.C Okoye chubaokoye@yahoo.com +234-8183541830 Street address City Postal code Country Position / Affiliation Faculty of Health Science and Technology, University of Nigeria, Enugu Campus, Nigeria. Enugu Nigeria Medical Rehabilitation Dept., Role Name Email Phone Fax Scientific Enquiries Prof Chuba G Okoye chubaokoye@yahoo.com +234-8183541830 Street address City Postal code Country Position / Affiliation University of University, Enugu Campus Enugu Nigeria Lecturer