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

NCT ID: NCT04678609

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-12-31

Brief 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.

Detailed 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.

Conditions

Osteoarthritis, Knee; Aging Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Open kinetic chain exercise

In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground

Closed kinetic chain exercise

In the OKC exercise group, participants will be taught by a physiotherapist about open kinetic chain exercises. Then, they will do the exercises at their home for eight weeks, with three session per week. The physiotherapist will contact the participants to monitor their adherence to the intervention. A diary is also provided to monitor their progress, pain level and any adverse events related to the intervention.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground

Control

The untreated control group will receive patient's usual care of local government hospital which includes information about clinical manifestations, risk factors, diagnosis, treatment and nursing care for knee OA. Control group did not receive any home exercises guidance.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground

Intervention Type: OTHER

Eligibility Criteria

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 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 6 months
• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Shazlin Shaharudin

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shazlin Shaharudin, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Locations

Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Mohd Bazlan Hafidz Mukrim, BSc

Role: CONTACT

jepem@usm.my

+609-767 2364

Wei Hui Ng, MSc

Role: CONTACT

ngweihui6@gmail.com

+6012-445 1638

Facility Contacts

Amran Ahmed Shokri, MBBS

Role: primary

amrankb@usm.my

09-767 6373

References

Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.

Reference Type: DERIVED

PMID: 35428274 (View on PubMed)

Other Identifiers

USM/JEPeM/19100645

Identifier Type: -

Identifier Source: org_study_id