Balance and Strength Exercise in Knee Osteoarthritis Patients

The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients

The aim of this study is to assess the effect of balance exercise on dynamic balance and physical function in 80 patients with different grades of primary knee osteoarthritis (KOA).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Balance exercise program; Other: Strengthening exercise program

Detailed Description

The study will include 80 patients with primary knee osteoarthritis divided into 4 groups according to the Kellgren and Lawrence grading scale (KL):

Group 1: 20 patients with grade I KOA Group 2: 20 patients with grade II KOA Group 3: 20 patients with grade III KOA Group 4: 20 patients with grade IV KOA

• Patients will undergo pre-exercise and post- exercise assessment with:

  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
  2. Modified Stare Excursion Balance test
  3. Timed up and Go test

• Exercise program includes:

  1. Lower extremity kinesthesia and balance exercise program
  2. Strength exercise program

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 00123
    • Alexandria university, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with primary knee osteoarthritis according to the EULAR recommendations 2010.
• Patients can complete at least stage 1 of balance and exercise program (minimum of 2 weeks)

Exclusion Criteria:

• Patients that cannot complete at least stage 1 of balance and exercise program
• Patients with medical conditions affecting postural balance including visual, inner ear and neurological problems.
• Patients with lower limb joint or bony problems other than primary knee osteoarthritis .
• Patients with secondary KOA.
• Patients who received intra- articular joint injection in 1 or both knees in the past 90 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: G I primary KOA; Exercise and balance training	Other: Balance exercise program; Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.; Other: Strengthening exercise program; Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.
Active Comparator: Group 2: G II primary KOA; Exercise and balance training	Other: Balance exercise program; Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.; Other: Strengthening exercise program; Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.
Active Comparator: Group 3: G III primary KOA; Exercise and balance training	Other: Balance exercise program; Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.; Other: Strengthening exercise program; Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.
Active Comparator: Group 4: G IV primary KOA; Exercise and balance training	Other: Balance exercise program; Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks. Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.; Other: Strengthening exercise program; Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks. Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain	Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains pain sub-score and a overall total score. The higher the score the worst the pain.	2-6 weeks
Assessment of stiffness	Using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), which contains stiffness sub-score and a overall total score. The higher the score the worst the stiffness.	2-6 weeks
Assessment of physical function	Using the time up and go test, where the patient is seated and asked to get up walk a distance turn around and return to chair and sit again. It is measured using a timer, the longer the patient takes the worst the physical function of the patient.	2-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Balance	Using the Modified star excursion balance test which measures the patients dynamic balance in several directions, giving the patient 3 attempts and measuring each time and taking a mean of the 3 measurements in each. An increase in the measurements means better dynamic balance and a smaller measurement means worse dynamic balance.	2-6 weeks

Collaborators and Investigators

• Sponsor: University of Alexandria
• Investigators: Principal Investigator: Yousra H Abdel Fattah, Alexandria University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 0105852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No