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.: PACTR202211564134826 Date of Approval: 22/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The chronic effects of supervised aerobic exercise on glycemic control and body composition in type-2 diabetes mellitus patients attending outpatient care unit at Goba Referral Hospital, Southeast Ethiopia: An interventional study
Official scientific title The chronic effects of supervised aerobic exercise on glycemic control and body composition in type-2 diabetes mellitus patients attending outpatient care unit at Goba Referral Hospital, Southeast Ethiopia: An interventional study
Brief summary describing the background and objectives of the trial Background: Diabetes mellitus and its complications continue to be one of the highest causes of morbidity and premature mortality. Lifestyle changes including exercise with continuous monitoring of hemoglobin A1c are advised to be used consistently in the management of diabetes mellitus. In this connection, exercise is underutilized in the management of type 2 diabetes mellitus in Ethiopia. Therefore, this study was intended to assess the effects of 12 weeks aerobic exercise on glycemic control and body composition in type 2 diabetes patients attending outpatient at Goba Referral Hospital.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/02/2020
Actual trial start date 01/02/2020
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 30/04/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group aerobic exercise three sessions per week, 40-60 min per session for 12 weeks structured aerobic exercise program which involved three sessions per week, 40-60 min per session for 12 weeks. 30
Control Group none not done not assigned not assigned 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Patients who were not willing to participate in the study and unable to give informed consent  Patients with any diabetic complications  Female patients  Age less than 35 and greater 65 years  Mentally and chronically ill patients.  Patients with respiratory and cardiovascular diseases  Patients who were not willing to participate in the study and unable to give informed consent  Patients with any diabetic complications  Mentally and chronically ill patients.  Individuals who were on fasting  Patients with respiratory and cardiovascular diseases Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 65 Year(s) Female
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 16/01/2020 Addis Ababa University
Ethics Committee Address
Street address City Postal code Country
0000 Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduced Hemoglobin A1c (HbA1c) level 12th week
Secondary Outcome Weight loss, Decreased BMI 12th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Goba Stadium 01 Goba 0000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University 0000 Addis Ababa University 1176 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Madda Walabu University 0000 Robe 247 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yohannes Dinku yohannesdinku34@gmail.com +251912299386 0000
City Postal code Country Position/Affiliation
Goba 247 Ethiopia Researcher Madda Walabu University
Role Name Email Phone Street address
Public Enquiries Tadele Regasa tdlrgs104@gmail.com +251922311812 0000
City Postal code Country Position/Affiliation
Goba 247 Ethiopia ResearcherMadda Walabu University
Role Name Email Phone Street address
Scientific Enquiries Diresibachew Haile direshaile@gmail.com +251911420620 0000
City Postal code Country Position/Affiliation
Addis Ababa 1176 Ethiopia Researcher at Adddis Ababa University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD data are available with the corresponding author and can be available on a reasonable request. Informed Consent Form November,2022 no Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
no No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information