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.: PACTR202106711008292 Date of Registration: 21/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title VIRTUAL REALITY EXERCISES VERSUS HIGH VOLUME RESISANCE TRAINING ON BODY FAT AND BLOOD BIOMARKERS IN OBESE ADULT FEMALES
Official scientific title VIRTUAL REALITY EXERCISES VERSUS HIGH VOLUME RESISANCE TRAINING ON BODY FAT AND BLOOD BIOMARKERS IN OBESE ADULT FEMALES
Brief summary describing the background and objectives of the trial Obesity is a complex phenomenon that increases the risk of cardiovascular diseases (CVDs), strokes and diabetes. There are negative changes in blood biomarkers that positively correlated with obesity and reported to be due to a state of low-grade systemic inflammation present in overweight and obese population .The prevalence of obesity is greater than it has ever been, with striking increases observed during the past 3 decades with higher incidence is reported among females compared with males. For years, low caloric intake and more energy expenditure are the first and most cost-efficient strategies to manage obesity. Resistance training can be best example for increasing energy expenditure and preventing loss of lean body mass caused by dietary restriction and aging process. Recent study concluded that greater volume of resistance training is required to decrease blood glucose and CRP concentrations and to promote significant reductions in body fat and lipid profile, however, lake of time to exercise is the main excuse for being physically inactive among obese female adult population. So, what have been challenging for researchers to find more motivational more encouraging and time efficient types of exercises, Virtual reality exercises or exergaming for example can combine exercise and gameplay with the intention of promoting greater physical activity among users who get greater enjoyment and feel more positive compared with other forms of physical exercise as well distract the users from the physical exertion of exercise. So, the objective of this trail is to compare the adding effect of virtual reality exercise versus high volume resistance training to low caloric diet on body fat and blood biomarkers (CRP, lipid profile and glycated hemoglobin "HbA1c)
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 13/06/2021
Actual trial start date 22/06/2021
Anticipated date of last follow up 13/12/2021
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group virtual reality exercises in addition to low caloric diet three times per week 12 weeks in addition to low calorie diet the participants will perform virtual reality exercises using the Kinect Adventures game, provided by the manufacturer, Microsoft. The game involved the Xbox 360 console with a Kinect motion sensor which records the player's movements by mapping the body position. Afterwards, the player's avatar is visualized in the game, thus replicating each real movement. The study will consider Kinect Adventures 4 mini-games (20,000 leaks, curvy creak, rally ball and reflex bridge) along with Just Dance 3 game, these games involve different whole-body movements and improves fitness. The main goal of each game is to avoid errors and complete the task in the shortest possible time. Each participant plays at the same level of difficulty then increases gradually. 20
Experimental Group high volume resistance training in addition to low caloric diet three times per week 12 weeks In addition to low caloric diet, participants of this group will perform high volume resistance training that is supervised by physical therapist to maintain the quality of execution of the study protocol and to ensure safety. 8 exercises are performed for different body segments (arms, legs, and trunk) that will be performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl, leg curl, triceps curl, and seated calf raise, resistance will be applied using free weights and TheraBand. After explaining the exercise to the participants each individual is tested for 10-15 repetition maximum then they will perform a 10–15 repetitions maximum (RM) in 3 sets per exercise, each exercise will be explained to participants and they will be instructed to inhale during the eccentric phase and expire during the concentric phase of each exercise, maintaining the speed of movements in a 1:2 proportion (concentric and eccentric contraction, respectively). The rest interval between sets is 60–120 seconds. The transition interval between exercises is 2–3minutes for both groups. Loads are individually adjusted for each exercise during the whole training period whenever the upper limit of programmed repetition 3 consecutive sessions. The load increases will be in the range of 2–5% for upper limb exercises and5–10%f or lower limb exercises. 20
Control Group low calorie diet daily 12 weeks each participant will follow low calorie diet that restricts daily calorie intake to be (1000 -1200 Kcal) per day and composed of 50-55% carbohydrates, 10-15% proteins, and 20-35% fats (saturated fats are restricted, all food should be high in fibers and have low glycemic index. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Sixty females, their age ranges between 40 to 60 years old. 2) With BMI between 30 to 40 kg/m. 3) Having sedentary lifestyle. 4) Physically independent. 5) Have willingness for participating in this study. 1) Uncontrolled diabetes mellitus. 2) Uncontrolled hypertension. 3) Systemic inflammatory diseases. 4) severe Neurological impairment. 5) severe Orthopedic impairment. 6) Cardiopulmonary disorders. 7) Recent surgery. 8) Pregnancy. 9) Smokers. 10) Use of oral contraceptive or hormone therapy. 11) Auditory or visual impairment. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 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 24/03/2021 Cairo university faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
7th Ahmed al zayat street, Dokki, Giza. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome blood biomarkers that includes C reactive protein, glycated hemoglobin and lipid profile that consist of cholesterol, triglyceride, high density lipoprotein , low density lipoprotein .body fat that includes total body fat mass, visceral fat, bodyfat ratio, hip waist ratio and skinfold thickness pre and post intervention
Secondary Outcome adherence to diet, quality of life questionnaire and fatigue severity questionnaire adherence to diet will be measured during the 12 week duration of the intervention , quality of life and fatigue severity questionnaires will be measured pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Ahmed el zayat street , Dokki , Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Ahmed Zamzam 7th Ahmed Elzayat st, Been Elsarayat, Dokki Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical Therapy Cairo University 7th Ahmed Elzayat street, Been Elsarayat, Dokki Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud Ismail AbdelAal 7th Ahmed Elzayat street, Been Elsarayat, Dokki Giza Egypt
Mohsen Mohamed Elsayyad 7th Ahmed Elzayate street, Been Elsarayat, Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Zamam ssaznaas@gmail.com +201228153636 Faisal king street
City Postal code Country Position/Affiliation
Giza Egypt physical therapist
Role Name Email Phone Street address
Scientific Enquiries Nabil Abdel Aal nabil.mahmoud@cu.edu.eg +21200133613 7 Ahmed Elzayat street, Been Elsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Mohsen Elsayyad dr_sayyad1@hotmail.com +201142663054 7 Ahmed Elzayate, Been Elsarayat, Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will provide the study results within 6 months of study completion. Clinical Study Report we will provide the study results within 6 months of study completion. we will publish the study in the scientific journal
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