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.: PACTR202012549421049 Date of Approval: 08/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF ADDING WEIGHT SHIFT TRAINING TO WEIGHT REDUCTION ON RISK OF FALLING IN OBESE FEMALES
Official scientific title EFFECT OF ADDING WEIGHT SHIFT TRAINING TO WEIGHT REDUCTION ON RISK OF FALLING IN OBESE FEMALES
Brief summary describing the background and objectives of the trial Balance is the ability to maintain orientation, muscle activities and biomechanics of the body through the integration of sensory information captured by the visual, vestibular and somatosensory systems. It is defined as the result of all the forces that act on the body. When we tend to be in desired position and orientation we say that we are in static balance, whereas when we move in a controlled manner, we are in dynamic balance. The purpose of the study is to: - Investigate the effect of weight shift training on risk of falling, fear of falling and isometric knee torque in obese females
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 Biodex balance system
Anticipated trial start date 14/12/2020
Actual trial start date
Anticipated date of last follow up 12/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group weight reduction program 3 MONTHS Dietary intake will be evaluated by using 24-h dietary recalls collected at the first visit. The weight loss program will be a caloric counting diet. An energy restriction, which corresponded to a reduction in energy intake of approximately 500-1000 kcal from the maintenance, will be fixed for all obese subjects. In order to achieve this energy restriction, the baseline resting metabolic rate will be measured by Harris bendict equation (HB) (Teasdale et al., 2006). The versions of the HB equation for women is as follows, with W equal to weight in kilograms, H the height in centimeters, and A the age in years: 665.1+(9.563×W)+(1.85×H)–(4.676×A) (Picolo et al., 2015). 30 Active-Treatment of Control Group
Experimental Group caloric counting diet and weight shift training on Biodex balance system 3 MONTHS This training mode allows for exercise in the most basic activities of weight shifting. The patient has the ability to shift weight in medial/lateral, anterior/posterior and diagonal planes. This can be done with both static and dynamic settings. During Weight shift exercise participants had to displace their center of gravity above and below to the limits established by the BBS, Six displacements outside the limits were required to complete the exercise, with the centre of gravity returning to the centre of the target between each displacement (Gusi et al., 2012). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Females only. - Age range from 19 to 25 years old. - Subject with BMI starting from 30 to 34.9 kg/m2 - - Fear of falling, with a score > 23 for the 16 item Falls Efficacy Scale International questionnaire (Gusi et al., 2012). - Participants engaged in sport activities. - Pregnancy. - Participants carrying diseases that may cause balance problems. - Subjects with disease requiring the daily intake of psychotropic drugs or affecting the vestibular system, in order to avoid any influence on balance measures (Gusi et al., 2012). - Subjects free of lower-extremity injury and other potential threats to balance, such as diabetes, neuropathy, stroke, and vertigo (Glave et al., 2016). - Subjects taking medication to treat depression which contributes to falls and an associated fear of falling (Jung., 2008). Adult: 19 Year-44 Year 19 Year(s) 25 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 01/03/2020 Ethical Committee of Faculty of Physical Therapy Cairo University Cairo Egypt
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Risk of falling each month
Secondary Outcome Fear of falling each month
Secondary Outcome maximum voluntary isometric contraction of quadriceps muscle each month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Modern University for Information and Technology El-hadaba El-Wosta, Mokatam, 5th district - Cairo, Egypt Cairo 11571 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hanaa Samir 60/92 Bulding El Hadaba El Wosta El Mokattam Cairo 11571 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hanaa Samir 60/92 El Hadaba El Wosta El Mokattam cairo 11571 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amal Hassan Street 9 El Mokattam Cairo 11571 Egypt
Nabil Mahmoud Talbia Haram Giza Giza 12511 Egypt
Hanan El Sayed Taha El hay El Thleth 6 October 6th October 12585 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanaa Samir s_hanaa@yahoo.com 01013113946 60/92 El Hadaba El Wosta El Mokattam
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Amal Hassan s_hanaa@yahoo.com 01013113946 60/92 El Hadaba El Wosta El Mokattam
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Professor in Basic Sciences
Role Name Email Phone Street address
Scientific Enquiries nabil mahmoud s_hanaa@yahoo.com 01013113946 60/92 EL HADABA EL WOSTA EL MOKATAM
City Postal code Country Position/Affiliation
Cairo 11571 Egypt Lecturer of Basic Sciences
Role Name Email Phone Street address
Scientific Enquiries Hanan El said s_hanaa@yahoo.com 01013113946 60/92 EL hadaba el wosta el mokatam
City Postal code Country Position/Affiliation
cairo 11571 Egypt Professor of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes International Physical Therapy Conference and International Publication Study Protocol Within one year Open access
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