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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