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.: PACTR201810713260138 Date of Approval: 23/10/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of variable frequencies of KBA exercises in adults with knee osteoarthritis
Official scientific title Effect of variable frequencies of kinesthesis, balance and agility exercises in adults with knee osteoarthritis: a randomized controlled trial
Brief summary describing the background and objectives of the trial Knee pain from osteoarthritis is one of the most common musculoskeletal complaints that bring people to their physician and /or rehabilitation. Knee osteoarthritis (OA) prevalence is expected to rise significantly in the upcoming decades due to increasing life expectancy and decreasing physical activity. Knee OA can cause pain, stiffness, swelling, joint instability and muscle weakness, all of which can lead to impaired physical function and decreased quality of life. Kinesthesia, balance and agility (KBA) exercise is a neuromuscular training reported to be beneficial for individuals with knee OA. However, the effectiveness of this approach still need to be elucidated. Moreover, the most optimal dosage of KBA remains unclear. The aim of this study is to determine the effects of KBA exercise program in adults with knee OA and to determine which frequency of application (i.e. twice weekly or three times weekly) would be more effective in achieving desired outcomes
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Knee osteoarthritis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/12/2017
Actual trial start date 01/10/2018
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date 01/01/2021
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 85
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Brief education plus ultrasound therapy plus stretching plus strengthening and aerobic exercises Twice weekly 8 weeks Participants will receive three stretching quadriceps stretching, hamstring stretching and calf stretching exercises. The strengthening exercises include isometric quadriceps exercise, seated knee extension exercise and lying leg curl exercise to be held for 15-30 seconds and repeat for 6 times. 28 Active-Treatment of Control Group
Experimental Group Twice weekly KBA exercise group 2x/Week 8 weeks Participants will receive KBA exercises 2x/week in addition to the interventions for the control group for 8 weeks 28
Experimental Group Thrice weekly KBA exercise group 3x/week 8 weeks Participants will receive 3x/Week of KBA exercise in addition to interventions for the control group for 8 weeks 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Aged between 35-65years 2. Participants must meet the clinical criteria for the diagnosis of knee OA according to American College of Rheumatology (ACR) criteria for unilateral or bilateral symptomatic knee OA. 1. Any history of knee, hip, ankle surgery prior to the study. 2. Peripheral vascular disease, 3. Any local or systemic infections 4. Any deformity in lower limbs 5. Rheumatic disease other than osteoarthritis 6. High-risk health status for exercise 7. Unresolved balance or neurological disorder 8. Intra-articular joint injection within 4 weeks of beginning the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 65 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 13/11/2017 Hospital Management Board Aminu Kano Teaching Hospital and National Orthopedic Hospital Dala Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
Post Office Road, Zaria Road, and Gwammaja, Kano Kano 700213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Physical function Before starting the intervention, at 4 weeks of intervention, 8th week after intervention, 3-month, 4-month and 6-month post randomization.
Secondary Outcome Pain, knee stability, proprioception, and quality of life Before starting the intervention, at 4 weeks of intervention, 8th week after intervention, 3-month, 4-month and 6-month post randomization.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhammad Abdullahi Wase Teaching Hospital Hospital road, Nassarawa, GRA, Kano Kano Nigeria
Aminu Kano Teaching Hospital Zaria road, Kano Kano Nigeria
National Orthopaedic Hospital Dala Dala, Kano Kano Nigeria
Murtala Muhammad Speacilist Hospital Kano State Kano 700231 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nil Nil Nil Nil Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Nil Nil Nil Nil Nigeria No sponsor
COLLABORATORS
Name Street address City Postal code Country
Associate Prof. Akindele O. Mukadas Zaria road, Kano Kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aysha Adhama aishapt@yahoo.com +2348033177622 Zoo road
City Postal code Country Position/Affiliation
Kano 700224 Nigeria Doctoral student
Role Name Email Phone Street address
Public Enquiries Aysha Adhama aishapt@yahoo.com +2348033177622 Zoo road
City Postal code Country Position/Affiliation
Kano 700224 Nigeria Doctoral student
Role Name Email Phone Street address
Scientific Enquiries Mukadas Akindele mukaakin@yahoo.com +2348035537101 Zaria Road
City Postal code Country Position/Affiliation
Kano 700224 Nigeria Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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