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.: PACTR202207637483065 Date of Approval: 11/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title 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
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 Physical activity three days per week 60 minutes Machine based aerobic intervention 10
Experimental Group Physical activity intervention three days per week 60 minutes per day for three months Floor aerobic exercise intervention 10
Experimental Group Physical activity intervention three days per week 60 minutes per day for three months combined aerobic exercise (floor and machine based) 10
Control Group Not applicable Not applicable Not applicable Not applicable 0 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. Getu Teferi 3. Friew Amare
Ethics Committee Address
Street address City Postal code Country
Debremarkos kebele 08 Debremarkos 269 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body fat percentage improvement after three months aerobic exercise intervention
Secondary Outcome body weight management 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
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
Role Name Email Phone Street address
Public Enquiries getu teferi teferigetu36@gmail.com +251936206383 6300
City Postal code Country Position/Affiliation
Debremarkos Ethiopia Debremarkos University Department of Sports science
Role Name Email Phone Street address
Principal Investigator Dejenie bizuneh debits1982@gmail.com +251936206383 6300
City Postal code Country Position/Affiliation
Debremarkos Ethiopia Debremarkos University Department of Sports science
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Background: Excess body weight is an important risk factor for mortality and morbidity from cardiovascular diseases, diabetes, cancers, and musculoskeletal disorders. 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. Methods and materials: 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. Based on inclusion and exclusion criteria 30 overweight and obese participants were selected and randomized to group either: floor aerobics intervention group (IG), n=10; machine (cross trainer and treadmill) aerobics IG, n=10 and combined (both floor & machine) aerobic training) IG, n = 10. Data was analyzed using paired t-test for within groups, one way ANOVA post hoc test for group comparisons and ANCOVA to control diet. Result: The findings of the study revealed that floor, machine and combined (both floor & machine) aerobic training group were significantly improved in body weight and body fat percentage (p<0.05; p=.000). There was no significant difference in body weight but there was a significant difference in mean body fat percentage improvement [F (2, 26) = 8.758, p=0.001] among the three aerobic training IGs. Post hoc tests showed there was a significant difference between floor and machine aerobic training (MD= -5.212, p = 0.016) and floor and combined (both floor and machine) aerobic training (MD= -6.834, p = 0.001). Comparing the estimated marginal means showed that the most body fat percentage was decreased in floor aerobic training (mean=23.104) compared to machine and combined aerobic training (mean=28.316, 29.937 respectively). Conclusion: It was concluded that floor aerobic training had mor Statistical Analysis Plan,Study Protocol After completing data collection Purpose of required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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