Balance and Strength Exercise in Knee Osteoarthritis Patients

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04227860
• Other study ID #: 0105852
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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