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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Berkiye Kırmızıgil, Asst. Prof contact

03926303067

berkiyekirmizigil@yahoo.com

Ender Angin, Asst. Prof contact

03926303067

ender.angin@emu.edu.tr

Cyprus1 site, 1 recruiting
  • Eastern Mediterranean University

    Famagusta, 99628

    Berkiye Kırmızıgil, Asst. Prof, 03926303067, berkiyekirmizigil@yahoo.com

    Recruiting

Other trials in Cyprus

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).

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 groups in NCT04183933
Study groupRoleWhat they receive
Pilates Exercise GroupActive comparatorPilates exercises will given for 6 weeks, 3 days in a week.
Receives: Other: Pilates Exercise
Combined Exercise groupActive comparatorCombined 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted3 Dec 2019
  2. Study start9 Dec 2019
  3. Primary completion24 Jan 2020 (estimated)
  4. Study completion10 Feb 2020 (estimated)

Resources

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)
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

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.

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