OKV Versus CKC for Biomechanics and Function in Mild Knee OA Patients

Phase

N/A

Condition

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT04678609

USM/JEPeM/19100645

Ages > 50
Female

Study Summary

Background: Clinical recommendations suggest exercises as the core treatment for knee osteoarthritis (OA) patients. However, the biomechanical modification following exercise therapy and its influence on pain remains unclear. The purpose of the study to compare the effectiveness of two different exercise programs, open kinetic chain (CKC) and closed kinetic chain (CKC) strengthening exercises, on pain and lower limb biomechanics for people more than 50 years old with painful mild grade knee OA.

Method: 66 individuals with mild knee OA, with knee pain in the previous one week, aged 50 years and above, and who have body mass index (BMI) between 18.9kg/m2 - 29.9 kg/m2 in Kelantan, Malaysia will be recruited in this study. Participants will be randomly allocated into three different groups, either OKC, CKC, or control groups. Participants in OKC and CKC groups will perform the exercises at their home three times per week for eight weeks. The control group will receive only the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA and printed materials will be given. The outcome will be measured before and after the intervention. Primary outcomes are self-reported pain, disability, and quality of life scores. Secondary outcomes include lower limb biomechanics during gait and sit-to-stand, and knee isokinetic strength.

Discussion: This study will compare the efficacy of two different home-based exercise intervention programs for people with mild grade knee OA. Findings will provide valuable information for creating an effective exercise program that could slow down the progression of OA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

female patients
aged above 50
body mass index (BMI) <30 kg / m2
diagnosed with grade I and II knee OA using Kellgren-Lawrence
have knee pain ≥ 2 on a VAS in the past week

Exclusion

Exclusion Criteria:

have neurological disorders
have implanted electrical devices
have non-ambulatory status
have significant cognitive impairment
presence of systemic inflammatory arthritis
have history of hip or knee arthroplasty
have history of trauma or surgical arthroscopy of either knee in the last 6 months
involved in a previous study that includes an exercise program within the last 6months
received a knee intra-articular injection within the last 3 months
receives anticoagulant therapy
have recent or imminent surgery within the last 3 months
have any medical co-morbidities that excluding them from participation in exercises

Study Design

August 01, 2020

December 31, 2022

Study Description

The primary aim of this randomized controlled trial (RCT) is to compare the effects of two different home-based exercise programs namely OKC and CKC strengthening exercise intervention, on pain, disability, and quality of life on individuals with mild grade knee OA. Our secondary aim is to compare the effectiveness of OKC and CKC strengthening exercises on lower limb biomechanics during walking gait and sit to stand task. We hypothesize that after eight weeks of intervention OKC and CKC groups will show more improvements in pain, disability, and quality of life scores (what about the secondary outcomes) than the control group.

For the CKC and OKC exercise group, participants will perform an 8-week individualized home exercise, a minimum of three sessions in a week. Each session lasts about 30 minutes, including 5 minutes of walking as warming up session and quadriceps and hamstring stretching as the cooldown session. Daily Paracetamol 3000mg will be provided to all three groups. However, the consumption depends on each participant's needs, and the participants need to record it in the diary given. The exercise diary will be given to each participant to ensure patients' adherence to home exercise. During the intervention phase, a designated research team member will contact the participants personally to encourage them to continue their exercises.

The untreated control group received the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA except the information related to exercise. The control group will not receive any home exercise guidance. Upon completing the trial, participants in the control group will receive either CKC or OKC exercises depending on their preference.

Connect with a study center

Universiti Sains Malaysia
Kota Bharu, Kelantan 16150
Malaysia
Active - Recruiting

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