Atatürk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
NCT Number: NCT06783452
The aim of this study is to investigate the effect of a clinical Pilates exercise program on reducing symptoms in individuals with hip osteoarthritis. The main questions it aims to answer are:
* Does a clinical Pilates exercise program have an effect on pain, range of motion, physical function, performance, spinal mobility, postural control, disability, self-efficacy, and quality of life in individuals with hip osteoarthritis? * Does a conventional therapeutic exercise program have an effect on pain, range of motion, physical function, performance, spinal mobility, postural control, disability, self-efficacy, and quality of life in individuals with hip osteoarthritis? Researchers will compare clinical pilates program to conventional therapeutic exercise program to see if exercise works to reducing hip osteoarthritis symptoms.
Participants will:
* Take clinical pilates or Conventional Therapeutic Exercise twice a week for 12 weeks * The patients will be assessed by a blind evaluator both before and after the treatment.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Izmir, 35360, Turkey (Türkiye)
The clinical Pilates group will perform 45-minute exercise sessions under the supervision of a physiotherapist twice a week for 12 weeks, focusing on fundamental spinal alignments and Pilates principles. The program will include exercises that engage all body segments and combine movement with breathing. Participants will progress to more advanced levels as long as they can maintain proper alignment. Clinical Pilates exercises are structured into three levels of difficulty, and participants who complete the current level without compromising alignment will advance to the next level. The Conventional Therapeutic Exercise group will participate in an exercise program under the supervision of a physiotherapist twice a week for 12 weeks. The program, consisting of stretching and strengthening exercises, will last approximately 45 minutes. Resistance bands will be used to facilitate progression. Based on the individual's perceived difficulty level, resistance bands will be introduced or adjusted by changing their color to increase or decrease resistance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clinical Pilates Session:
Each clinical Pilates movement will have three difficulty levels: beginner, intermediate, and advanced. The progression criteria for increasing difficulty will be determined by the prevention of compensatory movements, the ability to activate target muscles, achieving more controlled movements during exercise, and maintaining a more stable posture. This program will include standard hip-focused as well as full-body clinical Pilates movements.
Time frame: From enrollment to the end of treatment at 12 weeks
Pain intensity will be evaluated using the Visual Analog Scale (VAS). During the assessment, patients will be asked to mark the degree of pain they feel on a 100-mm horizontal line. The distance from the starting point to the marked point will be measured with a ruler, and the pain intensity will be recorded in millimeters.
The VAS, developed by Vas Price et al. (1983), is a validated and reliable tool for determining the perceived intensity of pain. It is simple to administer and widely used in clinical practice.
Time frame: From enrollment to the end of treatment at 12 weeks
Lumbopelvic stabilization will be assessed using the "Stabilizer Pressure Biofeedback Unit". Prior to the measurement, each participant will be instructed in the corset technique for contracting the Transversus Abdominis muscle while lying in a supine position. Participants will be asked to lie on their back with their knees bent (hook-lying position), maintaining a neutral and relaxed spinal alignment.
A pressure cell, inflated with air and connected to a stabilizer, will be placed under the lumbar spine. The manometer's baseline pressure will be inflated to 40 mmHg. Participants will then be instructed to contract their Transversus Abdominis muscle using the abdominal corset technique without moving the spine or pelvis and without holding their breath. They will be required to maintain this contraction for 5 seconds.
After three practice trials to ensure learning, participants will rest for 30 seconds. The actual measurement will consist of three repetitions of 10 seconds each.
Time frame: From enrollment to the end of treatment at 12 weeks
Static balance assessment was performed using a proprioceptive-stabilometric assessment machine (ProKin 252; TecnoBody, Prokin, Italy). The device consists of a force platform with a 55 cm diameter surface, a sampling rate of 20 Hz, and a sensitivity of 0.1.
For all participants, anterior-posterior stability, medial-lateral stability index, and total stability index were measured under two conditions: with eyes open and eyes closed. Participants were instructed to stand motionless on the fixed platform surface for 30 seconds with their eyes open. During this time, the minimal postural sway of the body was recorded by the device, and a report was generated. The same measurement was then repeated with eyes closed.
Higher scores indicate impaired postural stability, while lower scores represent normal postural stability
Time frame: From enrollment to the end of treatment at 12 weeks
The Active Normal Range of Motion (ANROM) of the participants will be evaluated in appropriate positions. If necessary, measurements will be taken using a universal goniometer, and the degree of limitation will be recorded.
In the supine position, hip flexion, abduction, and adduction ANROM will be assessed, while hip extension ANROM will be evaluated in the prone position.
Time frame: From enrollment to the end of treatment at 12 weeks
The physical function levels of the participants will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This assessment tool consists of three subscales: Section A evaluates pain severity, Section B assesses joint stiffness, and Section C measures physical function.
The scale includes 5 questions for pain, 2 questions for joint stiffness, and 17 questions for physical function. Each question is scored on a scale from 1 to 5, where:
Each subscale generates a total score independently. A lower score indicates better health status, while a higher score reflects worse health status. The scoring ranges are as follows:
Section A (pain): 5-25 Section B (joint stiffness): 2-10 Section C (physical function): 17-85
Time frame: From enrollment to the end of treatment at 12 weeks
The disability levels of participants will be assessed using the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS). HOOS-PS is a 5-item scale designed to evaluate symptoms and functional status related to hip osteoarthritis. This questionnaire was developed by OMERACT/OARSI.
Each question is scored on a scale of 0 to 4 based on the degree of difficulty, with a maximum possible score of 20. However, the scores are normalized to a range of 0-100, where 0 indicates the best functional status.
Time frame: From enrollment to the end of treatment at 12 weeks
The self-efficacy levels of participants will be assessed using the Arthritis Self-Efficacy Scale. This scale consists of 20 items evaluated on a 10-point visual scale and includes three subdimensions: self-efficacy for pain, self-efficacy for function, and self-efficacy for other symptoms.
Self-efficacy for pain involves the perception of the ability to reduce pain and maintain it at a low level. The first 5 items of the scale belong to this subdimension.
Self-efficacy for function measures the ability to perform functions affected by arthritis, particularly in the hand and foot joints. The next 9 items following the first 5 are included in this subdimension.
Self-efficacy for other symptoms evaluates the ability of individuals with arthritis to cope with existing symptoms. The final 6 items fall under this subdimension.
Each item is scored on a 10-point scale, ranging from "Not at all confident = 1" to "Very confident = 10." The total score can range from 20 (minimu
Time frame: From enrollment to the end of treatment at 12 weeks
The quality of life levels of the participants will be evaluated with SF-12. SF-12 consists of 8 sub-dimensions and 12 items including physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). The items related to physical and emotional role are answered as 'yes or no', while the other items have Likert-type options ranging between 3 and 6. Physical component summary (PCS)-12 score is obtained from general health, physical functioning, physical role and body pain sub-dimensions, while mental component summary (MCS)-12 score is obtained from social functioning, emotional role, mental health and energy sub-dimensions. Both FCI-12 and MCI-12 scores ranged from 0 to 100, with higher scores representing better health.
Time frame: From enrollment to the end of treatment at 12 weeks
The participant is asked to sit upright on a standard 43 cm high chair with their arms crossed over their shoulders. They are then instructed to stand up and sit down as many times as possible in 30 seconds, at the fastest pace they can. They are told that they can rest if they get tired. The number of stand-ups is recorded.
Time frame: From enrollment to the end of treatment at 12 weeks
The participant is asked to walk as fast as they can, but not run, for a distance of 40 meters. The time taken to complete the test is recorded.
Time frame: From enrollment to the end of treatment at 12 weeks
The participant is asked to climb up a 9-step stair, turn around, and climb back down. The time taken is recorded, and their ability to perform the functional task is observed.
Time frame: From enrollment to the end of treatment at 12 weeks
The participant is asked to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time taken to complete the test is recorded.
Izmir Katip Celebi University
Other
Investigation of the Effectiveness of Clinical Pilates in Hip Osteoarthritis: A Randomised Controlled Trial
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