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.: PACTR202208515182119 Date of Approval: 25/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF CLINIC AND TELEPHYSIOTHERAPY BASED EXERCISE ON PHYSIOLOGIC AND PSYCHOSOCIAL OUTCOMES IN PATIENTS WITH KNEE OSTEOARTHRITIS
Official scientific title EFFECTS OF CLINIC AND TELEPHYSIOTHERAPY BASED EXERCISE ON PHYSIOLOGIC AND PSYCHOSOCIAL OUTCOMES IN PATIENTS WITH KNEE OSTEOARTHRITIS
Brief summary describing the background and objectives of the trial This study investigated and compared the effects of a Clinic-based Strengthening Exercise with Video-based Telephysiotherapy Strengthening Exercise on Pain Intensity , Range of Motion, Muscle Strength, Disability and Health related Quality of Life in patients with knee osteoarthritis. This was with a view to ascertaining the effectiveness of telephysiotherapy for the management of knee osteoarthritis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 24/03/2021
Actual trial start date 24/03/2021
Anticipated date of last follow up 30/07/2021
Actual Last follow-up date 30/07/2021
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinic based Strengthening Exercise Three times a week Eight weeks Clinic based Strengthening Exercise is a circuit exercise module comprising knee flexion and extension warm-up in sitting (3-5 repetition), quadriceps isometric setting; quadriceps strengthening exercise; hamstrings clenches; wall squat and a cool down of knee flexion and extension 26 Active-Treatment of Control Group
Experimental Group Video based Telephysiotherapy Strengthening Exercise Thrice weekly Eight weeks Video based Telephysiotherapy Strengthening Exercise is a video-based version of a circuit exercise module comprising knee flexion and extension warm-up in sitting (3-5 repetition), quadriceps isometric setting; quadriceps strengthening exercise; hamstrings clenches; wall squat and a cool down of knee flexion and extension. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients experiencing stiffness for less than 30 minutes in the morning, having crepitus, and being older than 50 years of age. patients having OA grade of 3 or lower on the Kellgren/Lawrence classification based on plain radiographs. Patients with history of knee pain longer than 6 months (chronic knee OA) Patients who had other musculoskeletal problems associated with the knee joint (such as tendon or ligament tears), central or peripheral neuropathy, or other unstable medical conditions. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 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 24/03/2021 Health Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Physiotherapy Departments, Benue State University Teaching Hospital Makurdi 102004 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity Baseline, 4th and 8th week
Secondary Outcome Range of Motion, Muscle Strength, Disability and Health related Quality of Life Baseline, 4th and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benue State University Teaching Hospital Physiotherapy Departments, Benue State University Teaching Hospital Makurdi 970211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chidozie Mbada Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University Osogbo 220232 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chidozie Mbada Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University Osogbo 220232 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada cembada@oauife.edu.ng +2348028252543 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Henry Awosika thawoshika2000@gmail.com 08035392692 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Clinician
Role Name Email Phone Street address
Scientific Enquiries Henry Awosika thawoshika2000@gmail.com 08035392692 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Clinician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodological sound proposal to achieve aims in the research proposal.
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