- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07883824
Aquatic Exercise in Patients With Knee Osteoarthritis
The Effect of Aquatic Exercise on Central Sensitization and Functional Parameters in Patients With Knee Osteoarthritis: a Randomized Controlled Trial
The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mensure Aslan
- 전화번호: 90 386 280 50 31
- 이메일: mensure.aa@outlook.com
연구 장소
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Merkez
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Kırşehir, Merkez, 터키 (Türkiye), 40000
- 모병
- Kirsehir Ahi Evran University, Kırşehir, Merkez 40100
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연락하다:
- Mensure ASLAN
- 전화번호: +90 386 280 42 24
- 이메일: mensure.aa@outlook.com
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 40-65
- Individuals diagnosed with knee osteoarthritis
- Individuals with no cognitive impairments
- Volunteers for the study
Exclusion Criteria:
- Individuals who have undergone knee surgery
- Individuals presenting with signs such as fracture, malignancy, or infection
- Pregnancy
- Individuals with cognitive impairments who are unable to express themselves.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard physical group
Participants receive standard physical therapy sessions for knee osteoarthritis for 8 weeks, each session is 60minutes. |
Standard physical conventional therapy exercises for knee osteoarthritis. |
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실험적: Standard physical group and hydrotherapy
• Participants receive standard physical therapy sessions combined with hydrotherapy (pool therapy) sessions for knee osteoarthritis for 8 weeks, each session is 60 minutes. |
Standard physical conventional therapy exercises for knee osteoarthritis. Hydrotherapy (pool therapy) sessions tailored to standard physiotherapy for knee osteoarthritis. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Central Sensitization
기간: 8 weeks
|
The Central Sensitization Inventory is a valid tool for assessing psychological and sensory factors associated with central pain sensitivity in patients with knee osteoarthritis. The Central Sensitization Inventory demonstrates moderate reliability in patients who have developed central sensitization due to knee osteoarthritis. Part A consists of 25 items that assess an individual's symptoms of central sensitization; it is scored using a 4-point Likert scale. Part B assesses whether the patient has received a diagnosis of another condition within the family of central sensitization syndromes from a physician. A high score indicates severe central sensitization.Number of Items: Section A of the scale, which is included in the assessment, consists of 25 items. Item Scoring: Each item uses a 5-point Likert-type scale, ranging from 0 to 4 points (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always). Minimum Score: 0; Maximum Score: 100 |
8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale
기간: 8 weeks
|
Participants' pain intensity will be assessed. Pain intensity is indicated on a 10 cm straight line with anchor points representing "no pain" and "worst pain imaginable." The distance between the starting point and the point marked by the patient is measured in centimeters. An increase in this distance signifies an increase in pain intensity. This is an assessment method, ranging from 0 to 10 (or 0-100 mm), used to measure the severity of subjective symptoms-most commonly pain. A score of 0 indicates no pain; 1-3, mild pain; 4-6, moderate pain; 7-9, severe pain; and 10, unbearable, extreme pain. |
8 weeks
|
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Knee Injury and Osteoarthritis Outcome Score
기간: 8 weeks
|
Knee-related quality of life scales for patients with knee osteoarthritis are tools used to assess pain, function, and activities of daily living. They comprise 42 items across five distinct subscales. A higher total score indicates extremely severe pain in the knee, restricted movement, and loss of function. Scores range from 0 points to 100 points. |
8 weeks
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Algometer
기간: 8 weeks
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Central sensitization is assessed by measuring the Pressure Pain Threshold (PPT). Pressure will be applied to the quadriceps muscle using an algometer until the patient perceives pain. The procedure will be performed three times at 20-second intervals, and the average value will be calculated. Subsequently, the patient will immerse their foot and ankle in cold water (1-4°C) for 60-120 seconds. Following this, the PPT will be measured again at the same point on the quadriceps muscle using the algometer, and the total score will be calculated. A high score indicates that central sensitization is not present. An algometer is a physical device that provides objective measurements. Consequently, the results obtained from the device are not scores, but rather values expressed in units of applied pressure. A low score, on the other hand, shows that central sensitization is present. |
8 weeks
|
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SF-36 Quality of Life Scale (36-Item Short Form Health Survey)
기간: 8 weeks
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It measures an individual's quality of life. The questionnaire consists of 36 items and 8 sub-parameters (physical functioning, bodily pain, limitations due to physical problems, emotional well-being, social functioning, energy/fatigue, and general health perception). A high score on the SF-36 questionnaire indicates that the patient's health-related quality of life is very good. Based on the data obtained from the survey, scores ranging from 0 to 100 are calculated separately for 8 distinct sub-dimensions and for the 2 main components into which these dimensions are grouped. |
8 weeks
|
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Biodex Balance Scale
기간: 8 weeks
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Patients' static balance will be measured using the Biodex Balance System®. Patients will be asked to maintain a balanced standing position on the static platform. The anteroposterior index, mediolateral index, and overall index will be evaluated with eyes open and eyes closed. Each position will be tested three times, and the average value will be recorded. For dynamic balance, level two of the 8-level resistance scale (1 = least stable, 8 = most stable) will be used. |
8 weeks
|
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Beck Depression Inventory
기간: 8 weeks
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It is widely used to assess the severity of depression in patients. It is a questionnaire consisting of 21 items. The questionnaire has a total score ranging from 0 to 63 points. A high total score indicates a high level of depression severity. |
8 weeks
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Mini-Mental State Examination
기간: 8 weeks
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The Mini-Mental test, which measures cognitive functions quickly and in a standardized manner, will be administered in the clinical setting; memory, attention, language, and visuospatial skills are assessed. The total score for the 11 items across these five domains ranges from 0 to 30. A high score in the assessment indicates normal mental functions, while a low score points to cognitive impairment or dementia. |
8 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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