Balance and Strength Exercise in Knee Osteoarthritis Patients

NCT ID: NCT04227860

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-12-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Post-exercise training assessment will be done by an investigator not involved in the study and unaware of the grading of KOA or of the pre-exercise assessment.

Study Groups

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Group 1: G I primary KOA

Exercise and balance training

Group Type ACTIVE_COMPARATOR

Balance exercise program

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group 2: G II primary KOA

Exercise and balance training

Group Type ACTIVE_COMPARATOR

Balance exercise program

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group 3: G III primary KOA

Exercise and balance training

Group Type ACTIVE_COMPARATOR

Balance exercise program

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group 4: G IV primary KOA

Exercise and balance training

Group Type ACTIVE_COMPARATOR

Balance exercise program

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Yousra Hisham Abdel Fattah

Lecturer of Physical Medicine, Rheumatology and Rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yousra H Abdel Fattah

Role: PRINCIPAL_INVESTIGATOR

Alexandria University Faculty of Medicine

Locations

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Alexandria University, Faculty of Medicine

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0105852

Identifier Type: -

Identifier Source: org_study_id

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