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.: PACTR202207586810033 Date of Registration: 11/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Aerobic Exercise for management of Overweight and obesity
Official scientific title Effects of Three Different Aerobic Training Modalities on Body Composition in Overweight and Obese Adults
Brief summary describing the background and objectives of the trial BACKGROUND Excess body weight is an important risk factor for mortality and morbidity from cardiovascular diseases, diabetes, cancers, and musculoskeletal disorders, causing nearly three million annual deaths worldwide. Currently, overweight and obesity are the most significant public health challenges, affecting more than 1.9 billion adults worldwide (Chávez-Guevara et al., 2020). Obesity is a growing risk to the health of people in developed nations, and has been described as an epidemic that has become a global health concern (Goettler, Grosse, & Sonntag, 2017). Obesity/overweight is an emerging problem in Africa (Adom, Puoane, De Villiers, & Kengne, 2017). In 2014, more than 1.9 billion adults aged 18 years and older were overweight. In Ethiopia, the prevalence of being overweight and obese in the urban setting is 12.1% and 2.8% respectively. Also, a study on adults in Addis Abeba found that 25.7% and 24.7% of women and men respectively were overweight. There has been a widespread recommendation of all people to participate in physical activity to maintain a healthy life. As one of the most effective ways against these problems is exercise most specifically aerobic exercise, which can help reduce fat, lose weight, and change appearance. Aerobic exercise is a physical exercise that is performed when the body is fully supplied with oxygen (Sarojini, Priya, & Devi, 2019). Multiple studies prove that machine based exercise specifically the Arc trainer outperforms elliptical in important areas like calorie burn, muscular endurance, and work capacity and running on a treadmill generally burns calories faster than most other forms of in-home exercise (Kisan, Kisan, Anitha, & Chandrakala, 2012). As stated by (Taye, 2016), floor aerobic exercise should not be recommended during rapid weight loss. But, the results of (Biswas & Bose, 2019) study indicate that, both step aerobics training and floor aerobics training improved body composition in overweight and obese individuals. However there is a limitation of scientific study on the potential differences between the effect of floor and machine (treadmill and cross trainer running) based exercise on body weight loss and to decrease body fat percentage. Trainers in the study area have not common understanding, there was debate regarding the potential differences between the effect of floor and machine based aerobic exercise on body composition (weight loss and body fat percentage). OBJECTIVE The research design of this study was experimental design specifically pretest-posttest randomized group design examining the effect of three different aerobics training modalities on change of body composition (body weight and percent body fat. The purpose of this study was to investigate the effects of 12 weeks three aerobic training modalities on body composition among individuals with overweight and obesity in Debre markos university sport science gymnasium participants.
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 15/07/2021
Actual trial start date 15/07/2021
Anticipated date of last follow up 15/10/2021
Actual Last follow-up date 15/10/2021
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Machine aerobic intervention group three days per week for three months 60 minutes per day for three months Three types of aerobic exercise intervention for three experimental groups 10
Experimental Group Floor aerobic intervention three days per week 60 minutes Physical activity intervention 10
Control Group No intervention three days per week for three months 60 minutes per day for three months Combined floor and machine aerobic intervention group for three months 10 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Either male or female individuals who was categorized under overweight and obese, adult aged (30-40 years old), was participant in Debre Markos university sport science gymnasium, sedentary at least before one month, was cleared PAR-Q+ and had no previous injury such as bone fracture, muscle strain and ligament sprain, joint dislocation and other health complications (NCDs) were included in this study Individual who is obese class II and above was excluded from the study because obese class II and above individuals should start exercise participation with light intensity, but this study was focused on moderate intensity. Adult: 19 Year-44 Year 30 Year(s) 45 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 25/06/2021 1. Awoke Tibebu 2. Dr. Ashenafi kefyalew 3. Friew Amare
Ethics Committee Address
Street address City Postal code Country
Debremarkos kebele 08 Debremarkos 6300 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body fat percentage decreased after three month intervention
Secondary Outcome Physical fitness level improvement after three months aerobic exercise 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
Dejene Bizuneh Debremarkos, kebel 08 Debrmarkos 6300 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debremarkos University Debremarkos kebel 02 debremarkos 6300 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Getu Teferi teferigetu36@gmail.com +251936206383 Debremarkos kebele 08
City Postal code Country Position/Affiliation
Debremarkos 6300 Ethiopia Debremarkos University Department of Sports science
Role Name Email Phone Street address
Principal Investigator Getu Teferi teferigetu36@gmail.com +251936206383 Debremarkos kebele 08
City Postal code Country Position/Affiliation
Debremarkos 6300 Ethiopia Debremarkos University Department of Sports science
Role Name Email Phone Street address
Scientific Enquiries Getu Teferi teferigetu36@gmail.com +251936206383 Debremarkos kebele 08
City Postal code Country Position/Affiliation
Debremarkos 6300 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 within the trial registration record All of the individual participant data collected during the trial or Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Describe purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/06/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/06/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information