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.: PACTR202108761820758 Date of Approval: 26/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of a Structured Physical Activity Program in the Prevention of Sleep Insufficiency and Musculoskeletal Pain Among Adolescents in Kano, Nigeria: A Randomized Controlled Trial
Official scientific title Effects of a Structured Physical Activity Program in the Prevention of Sleep Insufficiency and Musculoskeletal Pain Among Adolescents in Nigeria
Brief summary describing the background and objectives of the trial Childhood and adolescence represent a period of rapid growth and development characterized by neuronal plasticity, formulation of self-concept, and the establishment of behavioural patterns that may enhance or diminish mental health. There is growing evidence indicating adolescents with physical health conditions also have a greater prevalence of mental and sleep disorders as well as musculoskeletal pain (MSK) than the general population (Aarons et al., 2008; Hedden et al., 2017; Nelson et al., 2013) (Van Dyk, Thompson, & Nelson, 2016; Lavato & Gradisar, 2014; Crawley et al., 2014; Gregory & Sadeh, 2012; Reigstad, Jorgensen, Sund, & Wichstorm, 2010; Moreau, Belanger, Begin, & Morin, 2009). This is said to be carried into adulthood if not managed properly (Aarons et al., 2008; Bardone et al., 1998; Wickrama, Wickrama, & Lott, 2009). Sleep loss is an important factor in the global burden of disease with collateral effects on cardiovascular and mental health as well as injury and violent death through human error. A vulnerable population such as adolescents may be facing sleep loss and associated musculoskeletal pain. According to the executive summary of the global action plan on physical activity 2018 - 2030 WHO (2018), regular physical activity is proven to help prevent and treat non-communicable diseases (NCDs) and can improve mental health, quality of life and well-being. Recent studies (Desjardins &Tanguay-Labonté, 2018; Brett et al., 2017; Xiong et al., 2017) had demonstrated positive effects of structured physical activity (SPA) on the quality/quantity of sleep and daily functioning of adolescents with various mental disorders. However, it is still not known whether a conditioned SPA can be used to prevent sleep loss and MSK pain among adolescents in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SPA trial
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2021
Actual trial start date 01/09/2021
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date 01/11/2021
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status 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
Parallel: different groups receive different interventions at same time 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 Structured Physical activity 5 times per week 60 minutes The sessions were as follows: i. Warm-up: these involve all participants jogging at the spot for 2 minutes, then followed by 1-minute rest, then 2 minutes jogging on the spot, 1-minute rest and final 1-minute jogging on the spot. ii. Stretches - These were carried by standing on both toes and stretching the hands in full extension while trying to stand at a spot with subsequent lower limb stretches as will be demonstrated to the teacher. The stretches also last for 5 minutes. iii. The 50 meters race were carried out in groups for a competition to take place. But all participants only had a chance to run for 20 minutes in total. The second session after school hours involved carrying a 2kg weight of sandbag to the 50-meter mark and back. 100
Control Group daily routine activities All days of the week no limited time Continue normal daily routine without any restriction 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants were eligible for the study if they fulfil the following criteria; 1. Between the ages of 13-17 years 2. Must be attending a public or private secondary school in the selected country. 3. Participants were willing to be enrolled and followed for 2 years duration. Any eligible participant who presents with any of the following conditions was excluded from the study; 1. Any obvious physical deformity or congenital malformation 2. Signs of any apparent or obvious disease condition 3. Inability to read and write in English or Hausa language Adolescent: 13 Year-18 Year 12 Year(s) 17 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 14/05/2021 College Health Research Ethics Committee Bayero University Kano Nigeria
Ethics Committee Address
Street address City Postal code Country
NO.51 NEW GWARZO ROAD BUK NEWSITE kano 234777 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Sleep insufficiency At baseline and 6 weeks post intervention
Secondary Outcome Musculoskeletal pain At baseline and 6 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Government secondary school No.24 Layin Makaranta, Karkasara Kano 234777 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Bashir Bello Flat 25C BUK staff QUarters Tarauni Kano 234777 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Bashir Bello Flat 25C BUK STAFF QUARTERS TARAUNI KANO NIGERIA KANO 234777 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Abdulbaqi Adamu Postgraduate Students Hostel, Bayero University Kano Kano 234777 Nigeria
Fatima Yahaya Aliyu DSS Staff Quarters Kano 234777 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator BASHIR BELLO bbello.pth@buk.edu.ng +2348037019137 Flat 25C BUK STAFF QUARTERS TARAUNI KANO
City Postal code Country Position/Affiliation
KANO 234777 Nigeria SENIOR LECTURER
Role Name Email Phone Street address
Public Enquiries ABDULBAQI ADAMU adamuabdulbaqi@yahoo.com +2347038316721 POSTGRADUATE HALL AMIUNU KANO TEACHING HOSPITAL
City Postal code Country Position/Affiliation
KANO 234777 Nigeria POSTGRADUATE STUDENT
Role Name Email Phone Street address
Scientific Enquiries FATIMA YAHAYA aliyufatima12@yahoo.com +2348034851104 DSS quarters
City Postal code Country Position/Affiliation
Kano 234777 Nigeria Senior Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data Sharing Statement Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available at the university repository for sharing. Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code will also be made available Immediately after publication for anyone who wishes to access the data. Data will be available indefinitely at a link that will be provided after the repository. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol From December 2021 till no time limit Open access for all
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