- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07767812
Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
2026년 8월 14일 업데이트: Ismail Saracoglu, Kutahya Health Sciences University
Investigation of the Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
This randomized controlled trial aims to investigate the effects of motivational interviewing added to a neuromuscular exercise and home exercise program on pain self-efficacy, exercise behavior, pain intensity, physical performance, and functional status in individuals with knee osteoarthritis.
Sixty individuals diagnosed with knee osteoarthritis will be randomly allocated to either an intervention group or a control group.
The intervention group will receive motivational interviewing in addition to neuromuscular exercise and a home exercise program, whereas the control group will receive neuromuscular exercise and the same home exercise program.
Outcomes will be assessed at baseline, immediately after the intervention, and six weeks after the intervention.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
56
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: İbrahim YUKSEL, Msc. PT
- 전화번호: 0539 222 88 46
- 이메일: ibrahimyuksel0308@gmail.com
연구 장소
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Türkiye
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Afyonkarahisar, Türkiye, 터키 (Türkiye), 03100
- 모병
- AFSÜ Health Application and Research Center, Department of Physical Therapy and Rehabilitation
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연락하다:
- Aynur EYVAZ, MD
- 전화번호: 00902742651100
- 이메일: aynureyvaz@afsu.edu.tr
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수석 연구원:
- İbrahim YUKSEL, Msc.
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수석 연구원:
- Ismail Saracoglu, Phd
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부수사관:
- Nuray EYVAZ, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Diagnosis of knee osteoarthritis according to American College of Rheumatology (ACR) criteria
- Kellgren-Lawrence radiographic grade ≥2
- Knee pain lasting longer than 3 months
Exclusion Criteria:
- History of joint arthroplasty
- Body mass index >40 kg/m²
- Neuromuscular or neurological diseases such as stroke, Parkinson's disease, or multiple sclerosis
- History of lower-extremity joint fracture
- Hip osteoarthritis
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Motivational Interviewing + Neuromuscular Exercise + Home Exercise
Participants in this group will receive motivational interviewing in addition to a supervised neuromuscular exercise program and a home exercise program.
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Motivational interviewing will be delivered individually in face-to-face sessions by a researcher trained and certified in motivational interviewing.
Sessions will focus on identifying individual barriers and goals, strengthening motivation and commitment to exercise, supporting self-efficacy, and preventing relapse.
The intervention will incorporate three stages: increasing exercise motivation, strengthening commitment to exercise, and relapse prevention.
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
The home exercise program will include isometric strengthening exercises for the quadriceps and hip adductor muscles, straight leg raising, assisted hip and knee flexion, and active knee flexion exercises.
Participants will perform the program five days per week, twice daily, for three weeks, with 10 repetitions of each exercise.
The program will be explained and demonstrated by a physiotherapist during the first session, and adherence will be followed by telephone contact.
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활성 비교기: Neuromuscular Exercise Program
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
|
Participants will perform neuromuscular exercise sessions five times per week for four weeks.
Each 60-minute session will consist of approximately 10 minutes of warm-up, 40 minutes of exercise, and 10 minutes of cool-down.
Exercises will include core stabilization and postural control, postural orientation, lower-extremity strengthening, functional exercises, and balance and proprioception exercises.
Exercises will be progressed according to participant tolerance and functional performance.
The home exercise program will include isometric strengthening exercises for the quadriceps and hip adductor muscles, straight leg raising, assisted hip and knee flexion, and active knee flexion exercises.
Participants will perform the program five days per week, twice daily, for three weeks, with 10 repetitions of each exercise.
The program will be explained and demonstrated by a physiotherapist during the first session, and adherence will be followed by telephone contact.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Exercise Self-Efficacy Scale (ESE)
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The Exercise Self-Efficacy Scale (ESE) measures a person's confidence in their ability to maintain regular physical activity or exercise when facing various internal and external barriers.
Different validated versions exist, including Albert Bandura's 18-item scale, an older adult 9-item scale, and a 10-item spinal cord injury adaptation.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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Pain Self-Efficacy Questionnaire (PSEQ)
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item self-report tool designed to measure a person's confidence in performing daily activities and functioning normally despite ongoing chronic pain.
It uses a 7-point scale from 0 to 6, yielding total scores between 0 and 60, where higher scores reflect stronger coping confidence.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numerical Pain Rating Scale
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The Numeric Pain Rating Scale (NPRs) is a fast, 11-point tool used to measure pain intensity.
Patients select a whole number from 0 (no pain) to 10 (worst pain imaginable) to rate their discomfort verbally or in writing.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention.
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The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a widely used, self-administered 24-item questionnaire that evaluates pain (5 items), stiffness (2 items), and physical function (17 items) in patients with knee or hip osteoarthritis.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention.
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Physical Performance 30-Second Sit-to-Stand Test (30s STS)
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The 30s STS measures lower-extremity functional strength by recording the total number of complete sit-to-stand repetitions performed within 30 seconds, with a higher number of repetitions indicating better performance.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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Physical performance timed up and go test (TUG)
기간: Baseline, immediately after 4 week intervention and 6 weeks after competition of the intervention
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The TUG measures functional mobility as the time, in seconds, required to stand up from a chair, walk 3 meters, turn, walk back, and sit down, with a shorter completion time indicating better performance.
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Baseline, immediately after 4 week intervention and 6 weeks after competition of the intervention
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Physical performance 40-meter Walking Test
기간: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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The 40mWT assesses walking speed by recording the time required to complete a 40-meter walking course, with a shorter completion time indicating better walking performance.
The results of the three tests will be reported separately and will not be combined into a composite score.
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Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 1일
기본 완료 (추정된)
2026년 11월 15일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 8월 11일
QC 기준을 충족하는 최초 제출
2026년 8월 14일
처음 게시됨 (실제)
2026년 8월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 14일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IbrahimPHDtez
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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