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.: PACTR202403583803304 Date of Approval: 27/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of core stability exercises combined with proprioceptive training on postural stability in obese adult females
Official scientific title Impact of core stability exercises combined with proprioceptive training on postural stability in obese adult females
Brief summary describing the background and objectives of the trial summary and background: Obesity is associated with postural instability, High body mass index (BMI) has an association with increased postural sway in obese, mainly in the medial-lateral (ML) direction for men and anteroposterior (AP) for women, and occurrence of falls in adults. Core stability training is very effective to strengthen muscles, increase flexibility, and to improve postural control and balance function for professional athletes and healthy people of all ages and genders. A proprioceptive exercise program demonstrated significant improvements in areas such as functional mobility, musculoskeletal endurance, balance, gait, helps in maintaining proper body posture and balance, and improves body control. Purpose of the study: To investigate the improvement of postural stability in response to core stability exercises and proprioceptive training in obese adult females.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 12/03/2024
Actual trial start date 15/03/2024
Anticipated date of last follow up 12/06/2024
Actual Last follow-up date 15/06/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 54
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core stability exercises and proprioceptive training in addition to low caloric diet 2 sessions per week 24 session of core stabilization exercises, 45 min per session 2 sessions per week for 12 weeks. proprioceptive training for 30 min per session 2 sessions per week for 12 weeks. 18 obese females will be engaged in a core stability exercises 45 min per session 2 sessions per week for 12 weeks and proprioceptive training program for 30 min per session 2 sessions per week for 12 weeks in addition to low caloric diet (1200 kcal/day), 18
Control Group proprioceptive training in addition to low caloric diet 2 sessions per week 24 sessions of proprioceptive training for 30 min per session 2 sessions per week for 12 weeks. 18 obese females will be engaged in proprioceptive training program in addition to low caloric diet (1200 kcal/day) 2 sessions per week for 12 weeks 18 Active-Treatment of Control Group
Control Group a core stability exercises program in addition to low caloric diet 2 sessions per week 24 session of core stabilization exercises, 45 min per session 2 sessions per week for 12 weeks. 18 obese females will be engaged in a core stability exercises program in addition to low caloric diet 18 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Females with BMI >24.9 kg/m • Age group between 18-24yrs. • Females with BMI < 24.9 kg/m • neuromuscular and neurological diseases • Any visual disability • History of vestibular disease Adult: 19 Year-44 Year 18 Year(s) 24 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 07/11/2023 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postural stability at the beginning of the study and the end of study 12 weeks
Secondary Outcome Body mass index (BMI) at the beginning of the study and at the end of the study 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy El Gaish Street Kafr Elsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza city 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza city 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
KHADIGA SAYED ABD ELAZIZ El haram street Giza city 12512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa ElMoslemany Alaa_Gaber@pt.kfs.edu.eg 01093845571 Basyoun Al Gharbia
City Postal code Country Position/Affiliation
Basyoun Al Gharbia 31778 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries AFAF BOTLA drafafmohamed@yahoo.com 01283126608 Sendpeace, Gamal Abd Al Naser Street
City Postal code Country Position/Affiliation
El Kanater El Khaeria 1122 Egypt Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries KHADIGA ABD ELAZIZ Info@pt.cu.edu.eg 01144418667 AL HARAM STREET
City Postal code Country Position/Affiliation
Giza city 12512 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in postural stability. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.” Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://pt.cu.edu.eg/ar/ 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