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.: PACTR202203890283588 Date of Approval: 14/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Eccentric versus concentric training for knee osteoarthritis treatment; randomized clinical trial.
Official scientific title Eccentric versus concentric training for knee osteoarthritis treatment; randomized clinical trial.
Brief summary describing the background and objectives of the trial Knee osteoarthritis (OA) is a prevalent progressive multifactorial joint disease and is showed by chronic pain and functional inability [1]. Knee OA records 80% of the burden of OA worldwide and increases with obesity and age [2]. Up till now, knee OA has no curable treatment except knee replacement which is considered as successful treatment at late stage of the disease, however, which handles considerable health costs [3]. Most researchers have moved to the prevention and treatment in the early stage of the disease [4]. Some researchers support the use of eccentric training over the use of concentric ones as follow; In 2002 Hakan et al., studied the comparison between concentric versus combined concentric-eccentric isokinetic training: effects on functional capacity and symptoms in patients with OA of the knee and found the eccentric contractions was safe, effective, and well tolerated for the patients with knee OA [6]. On the other hand, some researchers support the use of both types, in 2018 Vincent and choleages studied both resistance training types were effective in increasing leg muscle strength and giving improvement in walking exercise endurance time. The degree of strength gain was associated with pain relief not resistance exercise type [7]. Strength improvements from various exercises (concentric, eccentric, or combined) are related to pain reduction and reduction of pain impact on physical function. What is still unclear is which strength training type may be more safe, suitable, and effective for knee OA pain symptoms and reversing the OA-related strength decline. So, the aim of this study is to compare each type to use effectively and safely in patients with knee OA.
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 03/03/2022
Actual trial start date
Anticipated date of last follow up 01/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification 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
Control Group concentric training 20-30 repetitions 45 Patients (n=30) received graduated eccentric resistance training exercises for knee flexors and extensors. Patient in sitting position and patient is asked to squeeze the muscles on top of thigh and foot is lifted and leg must also be straightened. Hold for 6 seconds and the patient is asked to slowly lower the leg. 3 seconds rest was given between motions. 3 sets with 10 repetitions for each set were performed. 30 Active-Treatment of Control Group
Experimental Group eccentric training 20 - 30 repetitions 45 Patients (n=30) received graduated concentric resistance training exercises for knee flexors and extensors. We start with quadriceps, hamstring and Adductor set exercises. We then progress to flexion straight leg raising (SLR) with the patient supine and knee extended, we asked the patients to raise affected leg while knee is extended, hold 5 secs, and repeat 20-30 repetitions. Abducted and extended SLR also were done. Then we progress to squat exercises by a mini- squat (0-40) first, then progress as the symptoms improve. Prone hamstring Curl also done from prone position for 20-30 times. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
This study was delimited to patients of both genders, their age between 50-70 years old with symptoms of knee OA with grade 2 or 3 as judged by criteria of Kellgren and Lawrence 1957. Patients who have symptomatic knee osteoarthritis with limited knee range of motion also were included in the study. Patients having a history of cardiac diseases or dyspnea on exertion, patients with history of uncontrolled hypertension or peripheral neuropathy were excluded. Patients with a history of arthroscopy of either knee in the past year also were excluded. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 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 15/07/2020 research ethical committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 - Ahmed Elziat st. Ben Elsaryat - El dokki - Giza - Egypt giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome VAS NEFORE AND AFTER TTT
Primary Outcome WOMAC BEFORE AND AFTER TTT
Secondary Outcome ROM BEFORE AND AFTER TTT
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatients clinic of Kafer El Sheikh general hospital El Dostour St , In Front Of El Awqaf Bldgs , Downtown, Kafr El Sheikh Kafr El Sheikh 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ehab ali mhamed abdalah 7 ahmed elzayat st. ben elsarayat - eldokki GIZA Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor kafr elsheikh general hospital dostor st kafr elsheikh 16454 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
atef nodir 7 ahmed elziat st. ben elsaryat - eldokki giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab aBDALLLAH aliehab93@gmail.com 00201223674916 7 ahmed elzayat st. ben elsarayat - eldokki
City Postal code Country Position/Affiliation
GIZA 12612 Egypt LECTURER
Role Name Email Phone Street address
Public Enquiries ATEF NODIR atefneder@yahoo.com 0020122034134 DOSTOR ST
City Postal code Country Position/Affiliation
KAFR ELSHEIKH Egypt LECTURER
Role Name Email Phone Street address
Scientific Enquiries HANAN AFIFI ananafify@yahoo.com 00201119092772 tahrir st
City Postal code Country Position/Affiliation
giza Egypt lecturer
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 Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol ONE YEAR OPEN ACCESS
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