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.: PACTR202308724795310 Date of Approval: 24/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Immediate effects of exercise snacking on physical fatigue, mood, and pain in elderly adults with knee osteoarthritis
Official scientific title Immediate effects of exercise snacking on physical fatigue, mood, and pain in elderly adults with knee osteoarthritis
Brief summary describing the background and objectives of the trial Research has shown that there is a relationship between depressive symptoms, pain, and fatigue in patients with knee osteoarthritis. Exercise has also been found to be beneficial in reducing pain and fatigue, as well as improving mood, in patients with knee osteoarthritis. However, despite the evidence supporting the benefits of exercise for knee osteoarthritis, long bouts of exercise were found to increase fatigue and pain. However, breaking up the same volume of exercise into multiple bouts rather than performing it as one continuous bout may be beneficial for limiting knee pain in patients with knee osteoarthritis. This suggests that breaking exercise regimens into shorter bouts can be beneficial in reducing physical fatigue and pain, as well as improving as compared to continuous activity in elderly adults with knee osteoarthritis. The aim of this study was therefore to determine the immediate effect of exercise snacking on physical fatigue, pain, and mood in elderly adults with knee osteoarthritis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/08/2023
Actual trial start date 13/07/2023
Anticipated date of last follow up 25/10/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 37
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
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Continuous aerobic exercise A single bout 10 minutes Baseline data will be collected from participants before the study using validated questionnaires, including International Physical Activity Questionnaire (IPAQ), the Physical Activity Readiness Questionnaire (PARQ) for physical activity level and readiness, the Numerical Fatigue Rating Scale (NFRS) and Numerical Pain Rating Scale (NPRS) for fatigue and pain levels, and the Visual Analog Mood Scale (VAMS) for mood assessment. A bicycle ergometer (model, American Fitness BYK 800) will be used to administer 10 minutes of continuous exercise. The rate of perceived exertion (RPE) scale will be used to ascertain the exercise intensity at the end of the protocol. This protocol will be observed once, after which measurements of physical fatigue level using Numerical Rating Scale for Fatigue (NRSF), pain level using Numerical Pain Rating Scale (NPRS) and mood using the Visual Mood Scale will be taken. At the end of the protocol, this group will undergo 10 minutes of sitting (rest period) before leaving. 23 Dose Comparison
Experimental Group Exercise snacking Five bouts 2 minutes Baseline data will be collected from participants before the study using validated questionnaires, including the International Physical Activity Questionnaire (IPAQ), the Physical Activity Readiness Questionnaire (PARQ) for physical activity level and readiness, the Numerical Fatigue Rating Scale (NFRS) and Numerical Pain Rating Scale (NPRS) for fatigue and pain levels, and the Visual Analog Mood Scale (VAMS) for mood assessment. The intervention group will undergo five bouts of two-minute exercise snacking using a bicycle ergometer (model= American BYK 500), with a sitting period (rest) of two minutes in between each bout. The rate of perceived exertion (RPE) scale will be used to ascertain the exercise intensity at the end of the protocol. This protocol will be observed once, after which measurements of physical fatigue level using the Numerical Rating Scale for Fatigue (NRSF), pain level using the Numerical Pain Rating Scale (NPRS), and mood using the Visual Mood Scale will be taken. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals aged 60 years or older living in Benin City, Edo State hospital-based patients rather than community-dwelling patients, who are likely to have a worse outcome. Participants were diagnosed with mild to moderate KOA based on the Kellegren and Lawrence grade I–III classification and a physician's assessment using the American College of Rheumatology (ACR) classification. Participants with a baseline fatigue level ≤ 4 on a 0–10 scale using the Numerical Rating Scale for Fatigue (NRSF) within the past 30 days Participants with symptomatic pain ≤ 4 on a 0–10 scale using the Numerical Pain Rating Scale (NPRS) will also be included. Participants with signs of depressive symptoms Patients with asymptomatic osteoarthritis Patients with a baseline mild fatigue score of ≤ 4 on a 0–10 scale using the Numerical Rating Scale for Fatigue (NRSF) within the past 30 days Participants with a symptomatic pain score of ≤ 4 on a 0–10 scale using the Numerical Pain Rating Scale (NPRS) will also be included. Patients with neurologic disorders and cardiopulmonary conditions that could limit participation in aerobic exercises Participants who had recent or major surgery Participants with total knee replacement participants with other conditions such as rheumatoid arthritis, primary crystal arthritis, or cancer. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 85 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 15/08/2023 University of Benin teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Benin teaching Hospital , PMB 1111, Benin Lagos Express Road, Uselu, Benin City, Nigeria Benin City 300213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical fatigue Pre intervention and Post intervention
Secondary Outcome mood Pre intervention and Post intervention
Secondary Outcome Pain Pre intervention and Post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital PMB 1111, Benin Lagos Express Road, Uselu 300283, Benin City, Nigeria Benin City 300213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Kolawole Francis FRED REFUGE, EKOSODIN BENIN CITY 300283 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kolawole Francis OLuwatosin Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Ayoola Aiyegbusi Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Rev. Sr. Dr. Henrietta Fawole Department of Physiotherapy, School of Basic Medical Sciences, University of Benin Benin City 300213 Nigeria
Kolawole Francis Oluwatosin 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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Oluwatosin Kolawole francis20.kk@gmail.com +2348102796997 Medical complex, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Aiyegbusi Ayoola bogphysio@gmail.com +2348023212513 Department of physiotherapy, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Supervisor
Role Name Email Phone Street address
Scientific Enquiries Henrietta Fawole henrietta.fawole@uniben.edu +2348160580905 Department of Physiotherapy, University of Benin
City Postal code Country Position/Affiliation
Benin City 300213 Nigeria Supervisor
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. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal will be given access to the data for individual participant meta-analysis. Proposal should be directed to francis20.kk@gmail.com or bogphysio@gmail.com. To gain access, data requestors will need to sign a data access agreement, which will be provided through the email given above. Data are available for 5 years and will 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