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.: PACTR201811587617721 Date of Approval: 02/11/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Specific Aerobic Training on Glycemic Control, BMI and Selected Physiological Parameters Among Type II Diabetes Patients
Official scientific title Effect of Specific Aerobic Training on Glycemic Control, BMI and Selected Physiological Parameters Among Type II Diabetes Patients Attending Ayder Comprehensive Specialized Hospital, Mekelle City, Ethiopia (Experimental study)
Brief summary describing the background and objectives of the trial Background: Type II diabetes mellitus is a chronic metabolic disorder characterized by hyperglycemia and impaired insulin action and/or insulin secretion. Recent studies suggest that the effect of physical exercise on glycemic control, Body Mass Index and physiologic parameter remain often under investigated and therefore not appropriately addressed among people with diabetes. Objective: was to evaluate the effect of specific aerobic training on glycemic control, BMI and selected physiological parameters among type2 diabetes patient attending Ayder comprehensive specialized hospital Mekelle.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) None
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 14/12/2016
Actual trial start date 02/01/2017
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 28/04/2017
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ERC 0897 MU-CHS: Health research ethics Rerview Committee
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SPECIFIC AEROBIC TRAINING 48 times (three times per week): Tuesday,Thursday and Saturday (for 30 mints in each day) and training protocol was prepared three months (Tuesday,Thursday and Saturday (for 30 mints in each day) ) specific aerobic training /physical exercise ( Warming –up for 7 mint, Main part for 16 mint and Cooling down for 7 mint) was given for the intervention group three times per week (Tuesday,Thursday and Saturday (for 30 mints in each day) ) for 12 weeks by sport sciences professionals 10
Control Group routin physical excercise 48 times (three times per week for 12 weeks) (Tuesday,Thursday and Saturday) for 30 mini on each day 12 weeks (Tuesday,Thursday and Saturday) for 30 mini on each day simple physical exercise was given for the participant 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Study subjects included in this study were those who full fill the following inclusion criteria Type2 diabetes (as defined by American Diabetes Association)  Diabetes duration 4-5 years  Age between 40-50 years  Previous Inactive patients with type2 diabetes  Hemoglobin A1c value of 6.6 % to 9.9%  Reported clinical outcomes like cardiovascular events(myocardial infraction, stroke, and heart failure)  FBS<200 mg/dl  No smoking and No alcohol  No hypoglycemia background at rest or exercise  No regular exercise for the control group Study subjects excluded from this study were those who I. Participation in proper physical exercise (2 or more times weekly for 20 minutes or longer ) ii. Are unable to do physical exercise because of physical problem or illness iii. Reported clinical outcomes as all-cause mortality like cardiovascular events(myocardial infraction, stroke, and heart failure). iv. Blood pressure greater than 160/95mmHg. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 50 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 12/01/2017 Dr. Alemayohu Bayeray kahsay
Ethics Committee Address
Street address City Postal code Country
None Mekelle 1871 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Glycemic control level measured via Hemoglobin A1C test Before and three months after intervention
Secondary Outcome BMI, resting heart rate, respiratory rate, breathing hold time and VO2max. Before and three months after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ayder Comprehensive Specialized Hospital Diabetes Clinic none Mekelle 1871 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mekelle university None Mekelle 1871 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mekelle University college of natural sciences departement of sport sciences None Mekelle 1871 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Ayder comprhensive specialized hospital diabetes clinic and medical director office none Mekelle 1871 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AbAbreha Tesfay Tesfay abrehatesfay2008@gmail.com +251914045757 none
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia None
Role Name Email Phone Street address
Public Enquiries KALAYOU BERHE kalushaibex@gmail.com +251912117719 none
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia post graduate program coordinator
Role Name Email Phone Street address
Scientific Enquiries ALEMAYOHU KAHSAY alemayohubayeray@gmail.com +251914703261 none
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia Head of college research and community service office
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Significant improvement in Glycemic control, Body Mass Index, and selected physiological parameters was observed in intervention group. Statistically significant change in terms of decrease in Hemoglobin A1C, BMI, resting heart rate, respiratory rate, and increase in VO2max, and Breath holding time were seen in experiment group individuals whereas as the control groups no change was seen. Generally, the results obtained through this study proved independent “t” test comparison between experiment and control groups were shown positive effect on experimental group. After twelve week specific aerobic training experimental group showed better improvements on Glycemic control, Body Mass Index, and selected physiological parameters compare with control group at 0.05 levels confident. 22/09/2018 31/05/2019
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Result URL Hyperlinks Link To Protocol
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