Back to resultsThe Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
Primary Purpose
Osteo Arthritis Knee, Balance
Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Pilates Exercise
Combined Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
Individuals diagnosed with knee osteoarthritis II-III level according to the results of radiological evaluation by Kellgren and Lawrence
- Individuals aged between 40 and 70 years
- Individuals who have pain in his/her either of the knees in 3 month period and who have a VAS score of 3 or more
- Individuals who can walk 10 meters independently (with or without ancillary device)
Exclusion Criteria:
- Individuals with Body Mass Index 35 and above
- Individuals with a history of surgery or injury involving the lower limb within the last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
- Individuals who received hyaluronic acid or corticosteroid injections in the last year
- People with severe eyesight, hearing disabilities Individuals with neurological deficit or disorder
- Individuals with regular exercise habits in the last 6 months
- Individuals with inflammatory rheumatic diseases.
Sites / Locations
- Eastern Mediterranean UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pilates Exercise Group
Combined Exercise group
Arm Description
Pilates exercises will given for 6 weeks, 3 days in a week.
Combined exercises will given for 6 weeks, 3 days in a week.
Outcomes
Primary Outcome Measures
Fullerton Advanced Balance Scale (FAB-T)
It is a test that determines the functional balance state of individuals. The test has 10 parameters. These are: feet adjacent and eyes closed standing, reaching out forward to reach a shoulder-length object, 360 degrees of turning in right and left directions, stepping and passing over a 15.24 cm-long stair, tandem march, standing on one leg, eyes closed staying on the foam, double feet bounce, walking with head turning, reactive postural control. In this scale, which is scored between 0-40, a score between 0 and 4 is given for each item.
Secondary Outcome Measures
Berg Balance Test
is a routine test used in daily life, consisting of evaluation of 14 activities, requiring both dynamic and static balance. If the total score is between 0 and 20, there is a high risk of falling, between 21 and 40 there is a moderate risk of falling, between 41-56 there is a low risk of falling.
The Timed Up & Go (TUG) Test
TUG is a frequently used balance test to assess the functional mobility of individuals. It was developed by Podsiadlo and Richardson in 1991. Test measures the speed during many functional maneuvers such as standing up, walking, turning and sitting. In the test, the person is asked to get up from the chair, to walk for 3 meters with his/her own normal speed, to walk back and to sit on the chair and the time is recorded in seconds (sec). A shorter time indicates better balance and mobility. The starting position should be standardized. It is performed 3 times and the average value is recorded
Single Leg Stance Test on Hard Ground
the patient is asked to flex the knee with eyes open, hands on the hips, feet naked, and the hip in neutral position. The time is started as soon as the foot is removed from the ground and recorded in seconds. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts
Single Leg Stance Test on Foam Ground
Eyes open, hands on the hips, feet naked, hip in neutral position on the foam, participant is required to flex a knee. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts.
Push and Release Test
While the patient is in the standing position with the eyes open, the physiotherapist stands behind the person and places his/her hand on the person's scapula and participant leans backwards to push the hand of the physiotherapist.
The physiotherapist flexes the elbows to allow back movement of the body and supports the person's weight with his/her hands. When a person's shoulders and hips are in a fixed position just behind the heels, the physiotherapist suddenly raises participant's hands.
30 Seconds Sit and Stand Up Test
For proximal muscle strength of the lower extremity and endurance, this test is valid and reliable for adults. In his/ her starting position, the person sits on an armless armchair with his back straight, arms crossed in front of the chest and feet on the ground. With the starting of the measument, the person takes the sitting position from a full standing position and the exact numbers of standing uıp within 30 seconds are recorded. Less than 10 repetitions in 30 seconds show lower extremity muscle weakness
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
consists of 24 questions and is divided into 3 subgroups. WOMAC subgroups consisted of 5 pain-related questions, 2 stiffness-related questions, 17 physical function-related problems. In WOMAC assessment, each question is between 0-4 points. Subgroups are evaluated among themselves. According to this, the subgroup of pain is 0-20 points, the stiffness / rigidity is 0-8 points and the physical function subgroup is 0-68 points. During the evaluation of pain, the severity of pain in the last 24 hours is questioned. For stiffness / rigidity sub-parameters, first; the feeling of stiffness is defined and the joint stiffness felt within the last 24 hours in the evaluated joint is questioned. For physical function score, 17 activities that is being challenging for the participant due to arthralgia in the joint is being questioned.
Four Step Square Test
4 squares are formed perpendicular to each other on a flat surface. All squares are numbered. At the beginning of the test, the patient standing in frame 1 with her face directed to frame 2 is instructed to take steps in succession (2-3-4-1-4-3-2-1) to each frame as quickly as possible without touching it.
Individuals are said to be in contact with the ground with both feet in each frame (requiring the patient to step forward, backward, right and left sides). The completion time is recorded as a score. Two scores are measured, the best one is taken. The time is started when the first leg touches the ground on the second frame and ends with the last leg touching the ground on the first frame.
Full Information
NCT ID
NCT04183933
First Posted
November 29, 2019
Last Updated
December 9, 2019
Sponsor
Eastern Mediterranean University
1. Study Identification
Unique Protocol Identification Number
NCT04183933
Brief Title
The Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
Official Title
The Effect of Different Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
January 24, 2020 (Anticipated)
Study Completion Date
February 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to evaluate and compare the effects of Clinical Pilates Exercise Training and Combined Exercise Training on balance and functional status in individuals with knee Osteoarthritis (OA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilates Exercise Group
Arm Type
Active Comparator
Arm Description
Pilates exercises will given for 6 weeks, 3 days in a week.
Arm Title
Combined Exercise group
Arm Type
Active Comparator
Arm Description
Combined exercises will given for 6 weeks, 3 days in a week.
Intervention Type
Other
Intervention Name(s)
Pilates Exercise
Intervention Description
Pilates exercises will be given for 6 weeks, 3 days in a week.
Intervention Type
Other
Intervention Name(s)
Combined Exercise
Intervention Description
Combined exercise will be given for 6 weeks, 3 days in a week.
Primary Outcome Measure Information:
Title
Fullerton Advanced Balance Scale (FAB-T)
Description
It is a test that determines the functional balance state of individuals. The test has 10 parameters. These are: feet adjacent and eyes closed standing, reaching out forward to reach a shoulder-length object, 360 degrees of turning in right and left directions, stepping and passing over a 15.24 cm-long stair, tandem march, standing on one leg, eyes closed staying on the foam, double feet bounce, walking with head turning, reactive postural control. In this scale, which is scored between 0-40, a score between 0 and 4 is given for each item.
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Secondary Outcome Measure Information:
Title
Berg Balance Test
Description
is a routine test used in daily life, consisting of evaluation of 14 activities, requiring both dynamic and static balance. If the total score is between 0 and 20, there is a high risk of falling, between 21 and 40 there is a moderate risk of falling, between 41-56 there is a low risk of falling.
Time Frame
Evaluation will be applied on the first day and after 6 weeks
Title
The Timed Up & Go (TUG) Test
Description
TUG is a frequently used balance test to assess the functional mobility of individuals. It was developed by Podsiadlo and Richardson in 1991. Test measures the speed during many functional maneuvers such as standing up, walking, turning and sitting. In the test, the person is asked to get up from the chair, to walk for 3 meters with his/her own normal speed, to walk back and to sit on the chair and the time is recorded in seconds (sec). A shorter time indicates better balance and mobility. The starting position should be standardized. It is performed 3 times and the average value is recorded
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
Single Leg Stance Test on Hard Ground
Description
the patient is asked to flex the knee with eyes open, hands on the hips, feet naked, and the hip in neutral position. The time is started as soon as the foot is removed from the ground and recorded in seconds. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
Single Leg Stance Test on Foam Ground
Description
Eyes open, hands on the hips, feet naked, hip in neutral position on the foam, participant is required to flex a knee. The patient is asked to stand on one foot until the arms move or until the foot is dropped on the floor or until the time reaches 60 sec. For each foot, 3 attempts are made and the average time for each foot is recorded. Rest is allowed between attempts.
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
Push and Release Test
Description
While the patient is in the standing position with the eyes open, the physiotherapist stands behind the person and places his/her hand on the person's scapula and participant leans backwards to push the hand of the physiotherapist.
The physiotherapist flexes the elbows to allow back movement of the body and supports the person's weight with his/her hands. When a person's shoulders and hips are in a fixed position just behind the heels, the physiotherapist suddenly raises participant's hands.
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
30 Seconds Sit and Stand Up Test
Description
For proximal muscle strength of the lower extremity and endurance, this test is valid and reliable for adults. In his/ her starting position, the person sits on an armless armchair with his back straight, arms crossed in front of the chest and feet on the ground. With the starting of the measument, the person takes the sitting position from a full standing position and the exact numbers of standing uıp within 30 seconds are recorded. Less than 10 repetitions in 30 seconds show lower extremity muscle weakness
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Description
consists of 24 questions and is divided into 3 subgroups. WOMAC subgroups consisted of 5 pain-related questions, 2 stiffness-related questions, 17 physical function-related problems. In WOMAC assessment, each question is between 0-4 points. Subgroups are evaluated among themselves. According to this, the subgroup of pain is 0-20 points, the stiffness / rigidity is 0-8 points and the physical function subgroup is 0-68 points. During the evaluation of pain, the severity of pain in the last 24 hours is questioned. For stiffness / rigidity sub-parameters, first; the feeling of stiffness is defined and the joint stiffness felt within the last 24 hours in the evaluated joint is questioned. For physical function score, 17 activities that is being challenging for the participant due to arthralgia in the joint is being questioned.
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
Title
Four Step Square Test
Description
4 squares are formed perpendicular to each other on a flat surface. All squares are numbered. At the beginning of the test, the patient standing in frame 1 with her face directed to frame 2 is instructed to take steps in succession (2-3-4-1-4-3-2-1) to each frame as quickly as possible without touching it.
Individuals are said to be in contact with the ground with both feet in each frame (requiring the patient to step forward, backward, right and left sides). The completion time is recorded as a score. Two scores are measured, the best one is taken. The time is started when the first leg touches the ground on the second frame and ends with the last leg touching the ground on the first frame.
Time Frame
Change will be assessed from the baseline at 1 week and 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individuals diagnosed with knee osteoarthritis II-III level according to the results of radiological evaluation by Kellgren and Lawrence
Individuals aged between 40 and 70 years
Individuals who have pain in his/her either of the knees in 3 month period and who have a VAS score of 3 or more
Individuals who can walk 10 meters independently (with or without ancillary device)
Exclusion Criteria:
Individuals with Body Mass Index 35 and above
Individuals with a history of surgery or injury involving the lower limb within the last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
Individuals who received hyaluronic acid or corticosteroid injections in the last year
People with severe eyesight, hearing disabilities Individuals with neurological deficit or disorder
Individuals with regular exercise habits in the last 6 months
Individuals with inflammatory rheumatic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berkiye Kırmızıgil, Asst. Prof
Phone
03926303067
Email
berkiyekirmizigil@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ender Angin, Asst. Prof
Phone
03926303067
Email
ender.angin@emu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gozde Iyigun, Asst. Prof
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sevim Oksuz, Asst. Prof
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berkiye Kırmızıgil, Asst. Prof
Phone
03926303067
Email
berkiyekirmizigil@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
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