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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.: PACTR201308000587157 Date registered: 2013/07/11
TRIAL DESCRIPTION
Public title Exercise and Fasting blood glucose in Diabetes Mellitus
Official scientific title Blood glucose response to aerobic exercise training programme among patients with type 2 diabetes mellitus at the University of Nigeria Teaching Hospital, Enugu South-West, Nigeria
Brief summary describing the background
and objectives of the trial
Background and Objective: Control of all types of diabetes involves maintaining normal or near normal blood glucose levels through the appropriate therapy: insulin, oral hypoglycaemic agents, diet, and exercise. The aim of this study was to investigate the blood glucose response to aerobic exercise training among subjects with type 2 diabetes mellitus at University of Nigeria Teaching Hospital (UNTH), Enugu. Methods: Age matched randomized controlled trial design was used; subjects with diagnosis of type 2 diabetes mellitus attending the diabetes clinic of the UNTH participated in the study. Fifty four subjects (N=54) with type 2 diabetes mellitus (fasting blood sugar [FBS] of between110 & 225mg/dl) were age matched and randomized to two groups: exercise (n= 30) and control (n=24) groups. The exercise group involved in an 8 weeks continuous training (60%--79% HR max) of between 45 and 60 min, 3 times per week, while the controls group remain sedentary. SBP, DBP, VO2 max and FBS were assessed. Analysis of co-variance and Pearson correlation tests were used in data analysis Results: Findings of the study revealed significant effect of exercise training program on, SBP, DBP, FBS and VO2max. Changes in VO2max significantly and negatively correlated with changes in FBS (r= -.220) at p<0.05. Conclusion: It was concluded that aerobic exercise programme is effective adjunct in controlling blood glucose level among type 2 diabetic subjects.
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 2013-01-01
Actual trial start date 2013-01-08
Anticipated date of last follow up 2013-04-05
Actual date of last follow up 2013-04-05
Anticipated target sample size (number of participants) 60   
Actual target sample size (number of participants) 54   
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
Parallel: different groups receive different interventions at same time during study Randomised Stratification (Age matched) Double blind (External investigator ) Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Exercise group 3times per week 60minutes 8weeks training programme 30
Control group Control group Nil Nil 8weeks of sedentary 24

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Only those who volunteered to participate in the study were recruited, they were all stable, without any cardiac complications. Their blood pressure (BP < 140/90) was within normal range. Only those treated with or on diet and/or oral agents were recruited. They were sedentary and have no history of psychiatry or psychological disorders or abnormalities. Obese or underweight (BMI between 20 and 30 kg/m2), smokers, alcoholic, uncontrolled hyperglycemia (> 250mg/dl) and hypertension (Resting BP > 200/115) other cardiac, renal, respiratory disease and subjects on insulin therapy were excluded. Those involved in vigorous physical activities and above averagely physically fit were also excluded. 40 Years 55 Years 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 2012/12/04 Research and Ethics Committee of the UNTH, Enugu.
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital [UNTH], Enugu. Enugu Nigeria

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fasting blood sugar; VO2max At the end of 8weeks
Secondary Outcome Systolic blood pressure (SBP); Diastolic blood pressure (DBP) At the end of 8weeks At the end of 8weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital (UNTH), Enugu, Physiotherapy Department Enugu Nigeria

FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Medical Rehabilitation Dept., University of Nigeria, Enugu Campus Enugu Nigeria

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Nigeria, Enugu Campus Medical Rehabilitation Dept., University of Nigeria, Enugu Campus Enugu Nigeria University

COLLABORATORS
Name Street address City Postal code Country
Charles Ezema I Medical Rehabilitation Dept., University of Nigeria, Enugu Campus Enugu Nigeria
Nkama Rosemary F Medical Rehabilitation Dept., University of Nigeria, Enugu Campus Enugu Nigeria
Lamina Sikiru Medical Rehabilitation Dept., University of Nigeria, Enugu Campus Enugu Nigeria
Ezugwu UA University of Nigeria Teaching Hospital Enugu Nigeria
Amaeze AA University of Nigeria Teaching Hospital Enugu Nigeria
Nwankwo MJ Nnamdi Azikiwe University Awka Nigeria

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Charles Ezema gloryzemas@yahoo.com +2348037494795
Street address City Postal code Country Position / Affiliation
Medical Rehabilitation Dept.,University of Nigeria, Enugu Campus (UNEC) Enugu Nigeria Lecturer, UNEC
Role Name Email Phone Fax
Principal Investigator Dr Sikiru Lamina siklam_86@yahoo.co.uk +2348035319469
Street address City Postal code Country Position / Affiliation
Medical Rehabilitation Dept.,University of Nigeria, Enugu Campus (UNEC) Enugu Nigeria Lecturer, UNEC
Role Name Email Phone Fax
Scientific Enquiries Dr Austin Amaeze aamaeze@yahoo.com +2348033160350
Street address City Postal code Country Position / Affiliation
University of Nigeria Teaching Hospital,Enugu Enugu Nigeria Physiotherapist