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.: PACTR202001543440229 Date of Approval: 21/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of trampoline rebound exercise on seizure frequency and quality of life of persons with epilepsy.
Official scientific title Influence of rebound exercise on seizure frequency and behavioral outcome of persons with epilepsy: a randomized controlled trial
Brief summary describing the background and objectives of the trial Epilepsy is one of the most prevalent noncommunicable neurological conditions affecting more than seventy million persons around the globe, most of whom live in developing countries. It is an important cause of disability worldwide, and one of the most common non-infectious neurological disease in African countries, Nigeria inclusive. It has been reported that regular physical exercise generates psychological and physiological benefits for people with epilepsy. Individuals with epilepsy involved in exercise programs exhibit an improved mental state, become more sociable, and improve their psychosocial functioning and quality of life. The objective of the present study, therefore, is to investigate the effect of rebound exercise on seizure frequency and behavioral outcomes of persons with epilepsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 12/01/2020
Actual trial start date 29/01/2020
Anticipated date of last follow up 22/04/2020
Actual Last follow-up date 30/04/2020
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Not yet recruiting
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes 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 Rebound exercise group 3 times 30minutes The research assistants would administer aerobic exercise using trampoline rebounder. 25
Control Group non exercise control group once in a week 30minutes The participants will receive voluntary Counselling and Treatment’s routine service of routine care which include a wide range of social and medical services for health and medical cares. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patient diagnosed with epilepsy -Between 19-44years -Both male and female -Treatable causes of seizures - Diagnosis of a progressive neurological or systemic disorder -linguistic or cognitive inability to complete study questionnaires -Persons who have clinical laboratory test results outside the acceptable range -Participants with history of significant cardiovascular, pulmonary, orthopedic, or endocrinologic disease -participants with history of non-epileptic spells (pseudoseizures), or a history of medication noncompliance. Adult: 19 Year-44 Year 19 Year(s) 44 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 20/12/2019 Kano State Hospital management baord Ethics Commitee Nigeria.
Ethics Committee Address
Street address City Postal code Country
Post Office Road, kano kano 00234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency of seizure baseline, 4week, and 8weeks
Primary Outcome Quality of life baseline, 4week, and 8weeks
Secondary Outcome Mood states baseline, 4week, and 8weeks
Secondary Outcome Self esteem baseline, 4week, and 8weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialist Hospital and Abdullahi wase specialist Hospital Kano Nigeria Kano Kano Nigeria
Aminu Kano Teaching Hospital Hospital road, gyadi-gyadi Kano Kano Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Abdulsalam Mohammed Yakasai 1 katsina road kano, federal government secreteriat complex, kano state. Kano 00234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kano state Hospital management Board Post office road kano Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr. Sonill Mahraj Resevoir hills westvill campus Durban 4000 South Africa
Musa Sani Danazumi Hospital road Nguru 00234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ABDULSALAM MOHAMMED YAKASAI abdulpeace1@gmail.com +2348060840806 1 katsina road
City Postal code Country Position/Affiliation
kano 00234 Nigeria Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Sonill Maharaj maharajss@ukzn.ac.za +27834611413 reservoir hill
City Postal code Country Position/Affiliation
Durban 4000 South Africa supervisor
Role Name Email Phone Street address
Public Enquiries ABDULLAHI MOHAMMED MAHMUD drabdul@gmail.com +2348054444447 post office road
City Postal code Country Position/Affiliation
kano 00234 Nigeria Head ethics committee
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I'm going to share data on request. Informed Consent Form,Statistical Analysis Plan,Study Protocol As soon as we are done with data collection i.e after follow-up. The access is going to be controlled, data would be release on request to the researchers and trial registry.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
none 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