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.: PACTR202107784110960 Date of Approval: 19/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of a single bout of aerobic exercise on pain, mood, affect and fatigue in patients with knee osteoarthritis in Benin-city.
Official scientific title Effects of a single bout of aerobic exercise on pain, mood, affect and fatigue in patients with knee osteoarthritis.
Brief summary describing the background and objectives of the trial Knee OA (KOA), the most common type of OA is typically associated with pain, associated with negative affect, poor physical outcomes, and a number of negative psychological outcomes including depression, anxiety and fear of movement. Aerobic exercises have been reported to have positive effects on of pain, affects, severity of OA, depressive symptoms, anxiety, quality of life and functional performance. While studies have focused on the effect of aerobic exercises on pain, specific studies on the effects of aerobic exercise on mood, affect and fatigue in persons with KOA are limited. A study found that an acute bout of aerobic exercise results in an increase in positive affects that persists for at least 60 minutes post exercise in patients with chronic neck pain. Another study recorded that a single bout of aerobic exercise induced an analgesic effect which in turn improved the mood of patients with KOA. High-intensity long bouts of exercise have been reported to worsen symptoms such as pain, mood and affect in people with KOA. One review found that for a significant mood improvement one must exercise for at least 20 to 30 minutes and also found that affective responses improved regardless of duration, where a 25-minute condition led to a more positive engagement, compared with a 40-minute condition. The review also recommended that durations should span a wide range (from 10 to 60 minutes) to cover most possible prescriptions. Although little is known about the immediate effects of aerobic exercise on mood and affect in people with knee osteoarthritis (KOA), it is important to ascertain the duration of activity that will give the optimum health benefits in terms of mood and affect. Further as pain experience is influenced by cultural and demographic contexts; therefore, it is not known whether short bouts of exercises which has been found to improve clinical outcomes in patients with KOA in other climes will have the same effects on patients from the Nigerian pop
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/06/2021
Actual trial start date 30/06/2021
Anticipated date of last follow up 30/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
Recruitment status Active, not 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 10 minutes aerobic bicycle ergometry exercise single bout 10 minutes Participants will rest for 10 minutes on arrival at the laboratory after which they will complete the validated questionnaires assessing pain (VAS), mood (VAMS) and positive and negative affects (VAS-GVA-AFFECTSUBSCALE). Thereafter, the ActivPAL3™ micro activity monitor (PALtechnologies Ltd, Glasgow, Scotland, UK) will be attached to the right thigh of the participant using tegaderm dressing. Participants will then proceed to perform aerobic exercise on bicycle ergometer according to their duration assigned groups. Participants pedal at their comfortable pace, with the researcher checking exercise intensity at 5 minute intervals using the Rate of Perceived Exertion. Immediately after the single bout of exercise, participants will complete the VAS, VAMS and VAS-GVA-AFFECTSUBSCALE, 10 minutes after completing questionnaires participants will complete the VAS, VAMS and VAS-GVA-AFFECTSUBSCALE again. And finally 20 minutes after completing the questionnaires for the second time (10 minutes) the participants will and complete VAS, VAMS and I-PANAS-SF for the last time after which they are free to leave. There will be a follow up interview the next morning over the phone and participant’s pain, mood and affect will be assessed. 15
Experimental Group 15 minutes Aerobic bicycle ergometry exercise Single bout 15 minutes Participants will rest for 10 minutes on arrival at the laboratory after which they will complete the validated questionnaires assessing pain (VAS), mood (VAMS) and positive and negative affects (VAS-GVA-AFFECTSUBSCALE). Thereafter, the ActivPAL3™ micro activity monitor (PALtechnologies Ltd, Glasgow, Scotland, UK) will be attached to the right thigh of the participant using tegaderm dressing. Participants will then proceed to perform aerobic exercise on bicycle ergometer according to their duration assigned groups. Participants pedal at their comfortable pace, with the researcher checking exercise intensity at 5 minute intervals using the Rate of Perceived Exertion. Immediately after the single bout of exercise, participants will complete the VAS, VAMS and VAS-GVA-AFFECTSUBSCALE, 10 minutes after completing questionnaires participants will complete the VAS, VAMS and VAS-GVA-AFFECTSUBSCALE again. And finally 20 minutes after completing the questionnaires for the second time (10 minutes) the participants will and complete VAS, VAMS and I-PANAS-SF for the last time after which they are free to leave. There will be a follow up interview the next morning over the phone and participant’s pain, mood and affect will be assessed. 15
Control Group none none none this trial will not have a control group 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with ages ranging between 40 and above years who are diagnosed of unilateral or bilateral knee OA using doctor-diagnosis, American College of Rheumatology (ACR) classification or Kellgren and Lawrence classification (grade 2 or 3). Eligible participants who are willing to participate and also willing to give their informed consent Persons with rheumatoid diseases will be excluded from this study. Individuals with a history of unstable metabolic diseases or cardiopulmonary conditions that restrict participation in aerobic exercises will be excluded from this study. Individuals with neurologic or balance disorders, history of cerebrovascular accident, or head injury will be excluded from this study. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 28/06/2021 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 300283, Benin City. Edo State 300283 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Affect Baseline, Pretest, Post intervention, 10 minutes post intervention, 30 minutes post intervention, Next morning follow up.
Secondary Outcome Mood Baseline, Pretest, Post intervention, 10 minutes post intervention, 30 minutes post intervention, Next morning follow up.
Secondary Outcome Pain Baseline, Pretest, Post intervention, 10 minutes post intervention, 30 minutes post intervention, Next morning follow up.
Secondary Outcome Fatigue baseline, pre intervention, post intervention, 10 minutes post intervention, 30 minutes post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Benin Teaching Hospital University of Benin teaching Hospital, PMB 1111, Benin Lagos Express Road, Uselu 300283, Benin City Edo State Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Oghenekome Peter Ogba Medical Complex, University of Benin Benin City Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oghenekome PeterOgba medical complex, university of benin benin city edo state Nigeria Individual
Primary Sponsor Trust Orukpe medical complex, university of benin benin city edo state Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Mr. Femi Ogundiran Uiversity of benin Benin City Edo State Nigeria
Dr. Opeyemi Idowu Medical Complex, university of Benin Benin city Nigeria
Dr. Mary Agun University of Benin Teaching Hospital Benin City Nigeria
Mrs. Seun Kubeyinje university of Benin Teaching Hospital Benin City Nigeria
Oteme Honour Oghoroghene Medical Complex, University of Benin Benin City Nigeria
Orukpe Trust Odosa Medical Complex, University of Benin Benin City Nigeria
Peter Ogba Oghenekome Danielle Medical Complex, University of Benin Benin City Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oghenekome Peter Ogba komepeterogba@gmail.com 2348189841283 Medical Complex, University Of Benin
City Postal code Country Position/Affiliation
Benin city Edo State Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Opeyemi Idowu opeyemi.idowu@uniben.edu 2347036872825 Medical Complex, university of Benin
City Postal code Country Position/Affiliation
Benin city Edo State Nigeria Physiotherapist
Role Name Email Phone Street address
Public Enquiries Trust Orukpe trustorukpe1@gmail.com 2347048518953 Medical Complex, University of Benin
City Postal code Country Position/Affiliation
Benin City Edo State Nigeria Researcher
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 opelove4us@yahoo.com or opeyemi.idowu@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 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