Osteo Arthritis KneeNCT04183933
The Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
A study testing Pilates Exercise and Combined Exercise in people with Osteo Arthritis Knee and Balance, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Balance
- What is being tested?
- Pilates Exercise and Combined Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCyprus
- Study dates
- 9 Dec 2019to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta, 99628
Berkiye Kırmızıgil, Asst. Prof, 03926303067, berkiyekirmizigil@yahoo.com
About this study
Official title: The Effect of Different Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
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).
- Conditions
- Osteo Arthritis Knee, Balance
- Being tested
- Pilates Exercise, Combined Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates ExerciseOther
Pilates exercises will be given for 6 weeks, 3 days in a week.
Combined ExerciseOther
Combined exercise will be given for 6 weeks, 3 days in a week.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Exercise Group | Active comparator | Pilates exercises will given for 6 weeks, 3 days in a week. Receives: Other: Pilates Exercise |
| Combined Exercise group | Active comparator | Combined exercises will given for 6 weeks, 3 days in a week. Receives: Other: Combined Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change will be assessed from the baseline at 1 week and 6th week
Secondary outcomes (8)
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.
Measured: Evaluation will be applied on the first day and after 6 weeks
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
Measured: Change will be assessed from the baseline at 1 week and 6th week
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
Measured: Change will be assessed from the baseline at 1 week and 6th week
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.
Measured: Change will be assessed from the baseline at 1 week and 6th week
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.
Measured: Change will be assessed from the baseline at 1 week and 6th week
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
Measured: Change will be assessed from the baseline at 1 week and 6th week
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.
Measured: Change will be assessed from the baseline at 1 week and 6th week
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.
Measured: Change will be assessed from the baseline at 1 week and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start9 Dec 2019
- Primary completion24 Jan 2020 (estimated)
- Study completion10 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkiye Kırmızıgil, Eastern Mediterranean University
- Investigators
- Gozde Iyigun, Asst. Prof, Principal investigator, Eastern Mediterranean UniversitySevim Oksuz, Asst. Prof, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183933
- Sponsor's protocol ID
- ETK00-2019-0206
- Status last verified
- Dec 2019
- First submitted
- 29 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'
- ClinicalTrials.gov ID
- NCT04183933
- Acronym / sponsor ID
- ETK00-2019-0206
- Conditions
- Osteo Arthritis Knee, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 24 Jan 2020 (estimated)
- Study completion
- 10 Feb 2020 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Exercise Group | Active comparator | Other: Pilates ExercisePilates exercises will given for 6 weeks, 3 days in a week. |
| Combined Exercise group | Active comparator | Other: Combined ExerciseCombined exercises will given for 6 weeks, 3 days in a week. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals diagnosed with knee osteoarthritis II-III level according to the results of radiological evaluation by Kellgren and Lawrence
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates ExercisePilates exercises will be given for 6 weeks, 3 days in a week. | Other | Pilates Exercise Group |
| Combined ExerciseCombined exercise will be given for 6 weeks, 3 days in a week. | Other | Combined Exercise group |
Primary outcome
Fullerton Advanced Balance Scale (FAB-T)
Time frame: Change will be assessed from the baseline at 1 week and 6th week
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.
8 secondary outcomes
Berg Balance Test
Time frame: Evaluation will be applied on the first day and after 6 weeks
The Timed Up & Go (TUG) Test
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Single Leg Stance Test on Hard Ground
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Single Leg Stance Test on Foam Ground
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Push and Release Test
Time frame: Change will be assessed from the baseline at 1 week and 6th week
30 Seconds Sit and Stand Up Test
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Four Step Square Test
Time frame: Change will be assessed from the baseline at 1 week and 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gozde Iyigun, Asst. Prof principal investigator
Eastern Mediterranean University
Sevim Oksuz, Asst. Prof principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Exercise and Combined Exercise in people with Osteo Arthritis Knee and Balance, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berkiye Kırmızıgil, Asst. Prof (03926303067, berkiyekirmizigil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fullerton Advanced Balance Scale (FAB-T) (time frame: Change will be assessed from the baseline at 1 week and 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.