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- Ensaio Clínico NCT07767812
Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
14 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
56
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: İbrahim YUKSEL, Msc. PT
- Número de telefone: 0539 222 88 46
- E-mail: ibrahimyuksel0308@gmail.com
Locais de estudo
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Türkiye
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Afyonkarahisar, Türkiye, Turquia (Türkiye), 03100
- Recrutamento
- AFSÜ Health Application and Research Center, Department of Physical Therapy and Rehabilitation
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Contato:
- Aynur EYVAZ, MD
- Número de telefone: 00902742651100
- E-mail: aynureyvaz@afsu.edu.tr
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Investigador principal:
- İbrahim YUKSEL, Msc.
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Investigador principal:
- Ismail Saracoglu, Phd
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Subinvestigador:
- Nuray EYVAZ, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Exercise Self-Efficacy Scale (ESE)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Numerical Pain Rating Scale
Prazo: Baseline, immediately after the 4-week intervention, and 6 weeks after completion of the intervention
|
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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2026
Conclusão Primária (Estimado)
15 de novembro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
11 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
17 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças musculoesqueléticas
- Artrite
- Doenças articulares
- Doenças Reumáticas
- Osteoartrite
- Comportamento
- Osteoartrite, Joelho
- Atividade motora
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Disciplinas e atividades comportamentais
- Aconselhamento diretivo
- Aconselhamento
- Serviços de Saúde Mental
- Entrevista motivacional
Outros números de identificação do estudo
- IbrahimPHDtez
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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