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.: PACTR202405746557031 Date of Registration: 02/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Rebound Exercise on Cognition and Balance of Females with Overweight or Obesity
Official scientific title Effect of Rebound Exercise on Cognition and Balance of Obese and Overweight Females
Brief summary describing the background and objectives of the trial Balance instability has been reported to be common among females with overweight or obesity with associated fall risks. Despite the increasing reports of the negative impacts of obesity on balance and cognition, there is a scarcity of research aimed at evaluating effective interventions. Objective: To examine the effect of rebound exercise on cognition and balance among females with overweight or obesity.
Type of trial Non-Randomised
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 01/07/2023
Actual trial start date 01/07/2023
Anticipated date of last follow up 31/05/2024
Actual Last follow-up date 31/03/2024
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 17
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
Single Group Non-randomised 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 Rebound exercise 30 minutes in each session, three times a week for three weeks All the participants who volunteered and met the study criteria took part in the experiment. Each participant undergoes a pre-intervention assessment, which includes a cognitive assessment where each participant is given a copy of TMT A and a pen or pencil. The researcher then demonstrated the test to the participants using a sample sheet (TMT A-SAMPLE) after which the participant did the test. The researcher timed each participant as they followed the “trail” made by the numbers on the test. the time spent is recorded in seconds and the procedure is repeated for TMT Part B. Another pre-intervention assessment was the static balance test using the unilateral pedal tests (Unilateral pedal eyes open [UPEO], and Unilateral pedal eyes close [UPEC] tests). The process involved each participant determining their dominant lower limb and the researcher demonstrated the test with hands crossed over the chest, standing on the dominant limb, starting with the eyes open and alternating it with the eyes closed tests. The researcher timed each participant as they lifted the subordinate leg off the floor, and the UPEO and UPEC in alternating manner after 10 minutes of rest between each. The time spent with the subordinate leg sustained in the air is recorded and the procedure was done 3 times for each participant recording values of UPEO1, UPEC1, UPEO2, UPEC2, UPEO3, UPEC3. The third pre-intervention assessment was measuring dynamic balance using the 3Meter Backward Walk Test (3MBWT). Backwards walking is crucial for everyday activities like backing up to a chair, navigating through crowded spaces, opening doors, and avoiding sudden obstacles [33]. The procedure involved the researcher using a firm measuring tape to measure 3 meters on level ground. The researcher then demonstrates on the test starting with the tip of the heel on the same line as the 3-meter mark. The researcher recorded the time spent by each participant walking backwards as fast as possible through the 3 meters. 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
females with overweight or obesity who were within the age range of 17-35years. Having current cardiopulmonary and cardiorespiratory dysfunction as these conditions are contraindicated in moderate to high intensity aerobic exercise, having current atlantoaxial instability as rebounding aggravates neck pain in such condition, phobia for bouncing, lower limb arthritis, and pregnant females as any ballistic exercise is contraindicated in pregnancy. Adult: 19 Year-44 Year 17 Year(s) 35 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 29/01/2024 Health Research and Ethics Committee of ESUTH Teaching Hospital Parklane
Ethics Committee Address
Street address City Postal code Country
Enugu PortHarcourt Road, Ituku-Ozalla Enugu State 40001 Nigeria
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 14/06/2023 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu Enugu 01129 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cognitive performances Baseline measurement and three weeks post-intervention
Secondary Outcome Stationary balance, and dynamic balance Baseline measurement and three weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Evangel University Akaeze Kilometer 28 Enugu-Abakiliki Road, Okpoto. Akaeze Ebonyi State 491104 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Not Applicable Not applicable Not applicable Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Not applicable Not applicable Not applicable Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Chidiebele Petronilla Ojukwu Department of Medical Rehabilitation, College of Medicine, University of Nigeria Enugu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidiebele Petronilla Ojukwu chidiebele.ojukwu@unn.edu.ng +2348039470324 Department of Medical Rehabilitation, College of Medicine, University of Nigeria
City Postal code Country Position/Affiliation
Enugu 400010 Nigeria Senior lecturer in the University of Nigeria
Role Name Email Phone Street address
Public Enquiries Stephen Sunday Ede SSEde@uclan.ac.uk +447900430596 23 Grimshaw place
City Postal code Country Position/Affiliation
Preston United Kingdom University of Central Lancashire
Role Name Email Phone Street address
Scientific Enquiries Chidiebele Petronilla Ojukwu chidiebele.ojukwu@unn.edu.ng +2348039470324 Department of Medical Rehabilitation, College of Medicine, University of Nigeria
City Postal code Country Position/Affiliation
Enugu. 40010 Nigeria Senior Lecturer in the University of Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The summarised result will be shared as a peer-reviewed journal publication to the public including the participants. Also, supplementary and deidentified data will be available upon reasonable email request. Clinical Study Report,Statistical Analysis Plan,Study Protocol From 2024 to no end date Proposal should be directed to chidiebele.ojukwu@unn.edu.ng To gain access, data requestors will need to sign a data access agreement.
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