Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201308000587157 Date of Approval: 11/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Diabetes Mellitus,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/01/2013
Actual trial start date 08/01/2013
Anticipated date of last follow up 05/04/2013
Actual Last follow-up date 05/04/2013
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
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
Parallel: different groups receive different interventions at same time during study Randomised Stratification (Age matched) Double blind (External investigator ) Masking/blinding used Outcome Assessors,Participants
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 Age Category Minimum age Maximum 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 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 04/12/2012 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 Street address
Principal Investigator Charles Ezema gloryzemas@yahoo.com +2348037494795 Medical Rehabilitation Dept.,University of Nigeria, Enugu Campus (UNEC)
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer, UNEC
Role Name Email Phone Street address
Principal Investigator Sikiru Lamina siklam_86@yahoo.co.uk +2348035319469 Medical Rehabilitation Dept.,University of Nigeria, Enugu Campus (UNEC)
City Postal code Country Position/Affiliation
Enugu Nigeria Lecturer, UNEC
Role Name Email Phone Street address
Scientific Enquiries Austin Amaeze aamaeze@yahoo.com +2348033160350 University of Nigeria Teaching Hospital,Enugu
City Postal code Country Position/Affiliation
Enugu Nigeria Physiotherapist
REPORTING
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