- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07767812
Effects of Motivational Interviewing on Pain Self-Efficacy and Exercise Behavior in Individuals With Knee Osteoarthritis
14 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
56
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: İbrahim YUKSEL, Msc. PT
- Telefonnummer: 0539 222 88 46
- E-post: ibrahimyuksel0308@gmail.com
Studieorter
-
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Türkiye
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Afyonkarahisar, Türkiye, Turkiet (Türkiye), 03100
- Rekrytering
- AFSÜ Health Application and Research Center, Department of Physical Therapy and Rehabilitation
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Kontakt:
- Aynur EYVAZ, MD
- Telefonnummer: 00902742651100
- E-post: aynureyvaz@afsu.edu.tr
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Huvudutredare:
- İbrahim YUKSEL, Msc.
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Huvudutredare:
- Ismail Saracoglu, Phd
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Underutredare:
- Nuray EYVAZ, MD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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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Aktiv komparator: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Exercise Self-Efficacy Scale (ESE)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Numerical Pain Rating Scale
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2026
Primärt slutförande (Beräknad)
15 november 2026
Avslutad studie (Beräknad)
31 december 2026
Studieregistreringsdatum
Först inskickad
11 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2026
Första postat (Faktisk)
17 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
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