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.: PACTR202208489378019 Date of Approval: 05/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Exercise Modalities on Patients with Type 2 Diabetes
Official scientific title The Impact of Exercise Modalities on Blood Glucose, Blood Pressure and Body Composition in Patients with Type 2 Diabetes Mellitus in Debre Markos Referral Hospital, East Gojjam Zone, Ethiopia
Brief summary describing the background and objectives of the trial BACKGROUND Diabetes mellitus (DM) is a group of metabolic disorder characterized by an elevated blood glucose level as a result of limitation in insulin secretion or an inability to use insulin. There are four types of diabetes based on etiologic origin: Type 1 diabetes mellitus (T1DM), Type 2 diabetes mellitus (T2DM), gestational (diagnosed during pregnancy), and other specific origins (i.e., genetic defects and drug induced); however, most patients have T2DM (about 90%) followed by T1DM (5%– 10% of all cases) (care, 2015). Diabetes mellitus affects approximately 382 million adults thought the world, and is predicted to increase to 439 million adults by 2030 (Federation, 2013; Shaw, Sicree, Zimmet, & practice, 2010). T2DM accounts for 85–95% of all diabetes cases in the world (Shaw et al., 2010). A sedentary lifestyle is considered as one of the major risk factors for T2DM and its complications (Sullivan, Morrato, Ghushchyan, Wyatt, & Hill, 2005). An appropriate level of physical activity training is an effective therapeutic strategy for T2DM management (Sudeck, Höner, & Well‐Being, 2011). A recent research results revealed that no evidence on resistance exercise differs from aerobic exercise in impact on cardiovascular risk factors or safety in individuals with T2DM. Therefore, selecting one modality or the other may be less important than engaging in any form of PA (Yang, Scott, Mao, Tang, & Farmer, 2014). There is some scientific evidence that aerobic plus resistance training improves blood glucose management and treatment more than either modality alone (Church et al., 2010; D’hooge et al., 2011; Sigal et al., 2007). OBJECTIVE Therefore the purpose of the current study was to determine the most effective exercise interventions (aerobic exercise, strength exercise and combined aerobic plus strength exercise) on blood glucose level, blood pressure and body fat percentage among diabetes type two patients.
Type of trial RCT
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 31/12/2021
Actual trial start date 31/07/2021
Anticipated date of last follow up 31/10/2021
Actual Last follow-up date 31/10/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerobic exercise IG Three days per week for three months 60 minutes per day Aerobic exercise intervention: includes walking on the spot, running, step exercise, Jump; clap hands on jump Step right; tap left toe on floor etc. 10
Experimental Group Strength exercise IG Three days per week for three months 60 minutes per day Strength exercise intervention: includes Leg extension 2. Seated leg curl 3. Machine chest press 4. Seated machine row rear deltoids 5. Machine biceps curl 6. Machine triceps extension 7. Machine back extension 10
Experimental Group Combined IG Three days per week for three months 60 minutes per day Combined exercise intervention includes both aerobic plus strength exercises 10
Control Group No intervention Not considered No exercise for three months exercise intervention have not given 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Obese: BMI > 25.0 kgm-2 2. Pre-diabetic or Diabetic: Fasting blood glucose > 126 mg/dl-1 3. Medical clearance was required from all participants. 1. Uncontrolled blood pressure with no medication. 2. Known cardiovascular disease and/or pulmonary disease. 3. Any orthopaedic condition that will prevent them from exercising. Adult: 19 Year-44 Year 34 Year(s) 53 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 19/07/2021 Research and Community service committee
Ethics Committee Address
Street address City Postal code Country
Debremarkos University, Kebele 02 Debremarkos 6300 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Identify the most effective exercise modalities After three month intervention
Secondary Outcome Decreasing body fat percentage, blood glucose level and blood pressure of participants After three months intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debremarkos University Gymnasium Debremarkos University, Kebele 02 Debremarkos 6300 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator 6300 Debremarkos Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self sponsor 6300 debremarkos 269 Ethiopia Self sponsor
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tensay Ambelu ambelutensay@gmail.com +251936206383 6300
City Postal code Country Position/Affiliation
Debremarkos 269 Ethiopia Debremarkos University Department of Sports science
Role Name Email Phone Street address
Scientific Enquiries Getu Teferi teferigetu36@gmail.com +251936206383 6300
City Postal code Country Position/Affiliation
Debremarkos 269 Ethiopia Debremarkos University Department of Sports science
Role Name Email Phone Street address
Public Enquiries Getu Teferi teferigetu36@gmail.com +251936206383 6300
City Postal code Country Position/Affiliation
Debremarkos 269 Ethiopia Debremarkos University Department of Sports science
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share summary results of this article and All of the individual participant data collected during the trial, after de-identification Clinical Study Report,Informed Consent Form,Study Protocol We will share our data which includes pre-test and post-test data Reasonable request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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