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

NCT04678609 | Unknown DMC

• 1 other identifier: USM/JEPeM/19100645
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Aging Problems

Keywords

biomechanics; exercise

Outcome Measures

Primary Outcomes (3)

• Change from baseline of pain intensity score at post-intervention

  pain intensity will be assessed using a visual analogue scale. It consists of a bidirectional 10-cm straight line, where 0 cm is "no pain" and 10 cm is "worst imaginable pain," located at either end of the line. Patients will be instructed to draw a vertical mark on the line indicating their pain level.

  8 weeks

• Change from baseline of disability score at post-intervention

  Western Ontario and McMaster Universities Arthritis Index consists of a number of questions designed to assess the clinical severity of the disease (5 questions for pain, 2 questions for stiffness and 17 questions for physical function). It includes 24 questions, each question scored using a five-point scale (0-4) with higher scores representing greater levels of pain, stiffness and severity of the disease. The overall score (index) is determined by summing the scores across the three dimensions and the score ranges between 0-96 (derived from a 0-4 Likert scale).

  8 weeks

• Change from baseline of quality of life score at post-intervention

  The Osteoarthritis Knee and Hip Quality of Life in Malay Version consists of 43 items divided into five dimensions: physical activity, mental health, pain, social support, and social functioning Each item in the five dimensions is measured on a numerical rating scale from 0 to 10. Each item is scored on a scale from 0 to 10, and the normalized scores were obtained by computing the sum of item scores for each domain and calculated to a scale from 0 (worst) to 100 (best) possible quality of life.

  8 weeks

Secondary Outcomes (2)

• Change from baseline of speed during gait at post-intervention

  8 weeks

• Change from baseline of knee adduction moment during gait at post-intervention

  8 weeks

Study Arms (3)

Open kinetic chain exercise

EXPERIMENTAL

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.

Other: Exercise

Closed kinetic chain exercise

EXPERIMENTAL

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.

Other: Exercise

Control

NO INTERVENTION

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.

Interventions

Exercise OTHER

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

Closed kinetic chain exercise; Open kinetic chain exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (1)

• 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.

  PMID: 35428274 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shazlin Shaharudin, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Bazlan Hafidz Mukrim, BSc

CONTACT

+609-767 2364; jepem@usm.my

Wei Hui Ng, MSc

CONTACT

+6012-445 1638; ngweihui6@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 22, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)