Back to resultsBalance and Strength Exercise in Knee Osteoarthritis Patients
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Balance exercise program
Strengthening exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Alexandria University, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1: G I primary KOA
Group 2: G II primary KOA
Group 3: G III primary KOA
Group 4: G IV primary KOA
Arm Description
Exercise and balance training
Exercise and balance training
Exercise and balance training
Exercise and balance training
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04227860
Brief Title
Balance and Strength Exercise in Knee Osteoarthritis Patients
Official Title
The Effect of Combined Balance and Strength Exercise Program in Patients With Different Grades of Primary Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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).
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:
Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
Modified Stare Excursion Balance test
Timed up and Go test
Exercise program includes:
Lower extremity kinesthesia and balance exercise program
Strength exercise program
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
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.
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: G I primary KOA
Arm Type
Active Comparator
Arm Description
Exercise and balance training
Arm Title
Group 2: G II primary KOA
Arm Type
Active Comparator
Arm Description
Exercise and balance training
Arm Title
Group 3: G III primary KOA
Arm Type
Active Comparator
Arm Description
Exercise and balance training
Arm Title
Group 4: G IV primary KOA
Arm Type
Active Comparator
Arm Description
Exercise and balance training
Intervention Type
Other
Intervention Name(s)
Balance exercise program
Intervention Description
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
Intervention Name(s)
Strengthening exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of pain
Description
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.
Time Frame
2-6 weeks
Title
Assessment of stiffness
Description
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.
Time Frame
2-6 weeks
Title
Assessment of physical function
Description
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.
Time Frame
2-6 weeks
Secondary Outcome Measure Information:
Title
Dynamic Balance
Description
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.
Time Frame
2-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousra H Abdel Fattah
Organizational Affiliation
Alexandria University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University, Faculty of Medicine
City
Alexandria
ZIP/Postal Code
00123
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Balance and Strength Exercise in Knee Osteoarthritis Patients
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