The Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'

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).

Study Overview

• Status: Unknown
• Conditions: Osteo Arthritis Knee; Balance
• Intervention / Treatment: Other: Pilates Exercise; Other: Combined Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99628
    • Recruiting
    • Eastern Mediterranean University
    • Contact: Berkiye Kırmızıgil, Asst. Prof; Phone Number: 03926303067; Email: berkiyekirmizigil@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pilates Exercise Group; Pilates exercises will given for 6 weeks, 3 days in a week.	Other: Pilates Exercise; Pilates exercises will be given for 6 weeks, 3 days in a week.
Active Comparator: Combined Exercise group; Combined exercises will given for 6 weeks, 3 days in a week.	Other: Combined Exercise; Combined exercise will be given for 6 weeks, 3 days in a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change will be assessed from the baseline at 1 week and 6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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.	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.	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	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.	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.	Change will be assessed from the baseline at 1 week and 6th week

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Principal Investigator: Gozde Iyigun, Asst. Prof, Eastern Mediterranean University; Principal Investigator: Sevim Oksuz, Asst. Prof, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): January 24, 2020
• Study Completion (Anticipated): February 10, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: ETK00-2019-0206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No