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.: PACTR202203771782147 Date of Approval: 29/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acute effect of exercise snacking on physical and mental fatigue amongst university undergraduates with induced mental fatigue- A pilot study
Official scientific title Acute effect of exercise snacking on physical and mental fatigue amongst university undergraduates with induced mental fatigue- A pilot study
Brief summary describing the background and objectives of the trial Fatigue is an unpleasant physical or mental exertion with a cognitive and emotional component that is described as exhaustion that is not eased by standard energy-recovery measures. Its duration and intensity vary, and it reduces the ability to conduct normal activities to varying degrees. There is a high prevalence of fatigue (59.8%) among the student population, and this has been reported to impact functional performance. Further, student-related fatigue may be as a result of stressors such as bulky course loads, extracurricular activities, work commitments, social activities, long lecture sessions without breaks and other factors which include concerns about academic grades. These stressors may further escalate fatigue levels and subsequently impact exercise engagement, thereby worsening academic output and quality of life. A growing body of evidence proposes that interrupting continuous sitting (e.g., every 20-30 minutes) with even short-term (e.g., 2-3 minutes) bouts of standing and light activity can provide not only cardio-metabolic, musculoskeletal and anti-fatigue benefits but also cognitive benefits associated with academic achievement. Given that exercise is cheap and with emerging evidence suggesting that exercise may be easily accessible to prevent or reduce study-related fatigue, it may therefore be necessary to determine how different bouts of exercise affect the dimensions of fatigue in students who are mentally fatigued. Furthermore, exercise has been shown to improve fatigue level of students, as demonstrated in a recent study which found an improvement in fatigue among university students with high levels of study-related fatigue who engaged in low intensity exercising (de Vries et al. 2016). Currently there is dearth of studies on the effect of a moderate bout of single exercise relative to multiple shorter exercise bouts (i.e., exercise snacking) on physical and mental fatigue among undergraduate students who are mentally fatigued.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Exercise bouts and fatigue
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical Activity Intervention
Anticipated trial start date 29/04/2022
Actual trial start date
Anticipated date of last follow up 30/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
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 30 minutes aerobic bicycle ergometry exercise Single Bout 30 minutes Participant will complete the consent form and the 0-10 numerical rating scale for physical and mental fatigue (NRS-F SCALE) for the past 7days in the Physiotherapy laboratory of the University of Benin. International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to measure the level of physical activity. in the past 7 days. Thereafter participants will be induced with mental fatigue using an electronic version of incongruent Stroop task (that is., identifying colours used to display series of words at a self-selected pace for 10 minutes) on a tablet app (HUAWEI Mediapad T310;model number-AGSWO9). Participant will complete the 0-10 NRS-F SCALE for physical and mental fatigue prior to the commencement of 30-minutes bicycle ergometry exercise. The researcher will then open the sealed envelope in the presence of the participants to determine if participant is in the 30-minutes exercise group. If in this group, the participant will then proceed to perform 30-minutes of aerobic exercise on bicycle ergometer (model, American Fitness BYK 800) at a self-selected pace. Immediately after the 30-minutes exercise, participants will complete the 0-10 NRS-F SCALE for physical and mental fatigue and also the 0-10 rate of perceived exertion scale. At the end of the exercise, participants would sit for 5 minutes to cool down before departing the laboratory. 15
Experimental Group Three bouts of 10 minutes aerobic bicycle ergometry exercise Three bouts Three bouts of 10 minutes per bout with 5 minutes of rest period Participant will complete the consent form and the 0-10 numerical rating scale for physical and mental fatigue (NRS-F SCALE) for the past 7days in the Physiotherapy laboratory of the University of Benin. International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to measure the level of physical activity. in the past 7 days. Thereafter participants will be induced with mental fatigue using an electronic version of incongruent Stroop task (that is., identifying colours used to display series of words at a self-selected pace for 10 minutes) on a tablet app (HUAWEI Mediapad T310;model number-AGSWO9). Participant will then complete the 0-10 NRS-F SCALE for physical and mental fatigue prior to the commencement of each bout of 10-minutes bicycle ergometry exercise. The researcher will then open the sealed envelope in the presence of the participants to determine if participant is in the 3 bouts of 10-minutes exercise group. If participants are in this group, this participant will then proceed to perform each bout of 10-minutes of aerobic exercise on bicycle ergometer (model, American Fitness BYK 800) at a self-selected pace. Immediately after each bout of 10-minutes exercise, participants will complete the 0-10 NRS-F SCALE for physical and mental fatigue and also the 0-10 rate of perceived exertion scale. At the end of each bout of 10-minutes exercise, participants will rest for 5 minutes before commencing the next bout of 10-minutes exercise. 15
Control Group none none none none 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Full-time students aged 18 years and older Students who reside within the school hostels Students without any cognitive disorder or musculoskeletal disorders Students who can read and write English language Post-graduate and part-time students (Masters and doctoral students) Students who have cognitive and musculoskeletal impairments Students leaving outside the school campus Adult: 19 Year-44 Year 18 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 12/12/2022 Research Ethics Committee College of Medical Sciences University of Benin
Ethics Committee Address
Street address City Postal code Country
PMB. 1154, Ugbowo, Benin City Benin city 300213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mental and physical fatigue Pretest, post intervention, 10 minutes post intervention, 30 minutes post intervention
Secondary Outcome Rate of perceived exertion 10 minutes post intervention, 30 minutes post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin University of Benin, PMB. 1154, Ugbowo, Benin City, Nigeria. Benin City 300213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Daniel Obode Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Daniel Obode Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Rev. Sister. Henrietta Fawole Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Dr. Opeyemi Idowu Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Mr. Yinka Akinrolie University of Manitoba, 66 Chancellors Cir, Winnipeg Manitoba R3T 2N2 Canada
Dr. Martins Nweke Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Prof. Kayode Oke Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Daniel Obode Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Ogbu Vivian Ogechukwu Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Agbona Ese Joy Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Daniel Obode danobode22@gmail.com +2347065455155 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Henrietta Fawole henrietta.fawole@uniben.edu +2348160580905 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Opeyemi Idowu opeyemi.idowu@uniben.edu +2347036872825 Department of Physiotherapy, School of Basic Medical Sciences, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researcher who provide a methodologically sound proposal will be given access to the data for individual participant meta-analysis. Proposal should be directed to henrietta.fawole@uniben.edu, to gain access, data requestors will need to sign a data access agreement which will be provided through the email given above. Data would be available for 5 years ans would be sent on request.
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