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IRCT20250811066819N1 IRCT 2025-08-13 Kharazmi University Amplifying Comprehensive exercise with Pre-Exercise Interaction for Patients with Knee Osteoarthritis: Protocol for A Randomized Controlled Trial Amplifying Comprehensive exercise with Pre-Exercise Interaction for Patients with Knee Osteoarthritis: Protocol for A Randomized Controlled Trial 2025-10-01 anticipated 90 Complete https://irct.ir/trial/85488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization will be performed in a 1:1:1 ratio using a computer-generated sequence (Random.org). Allocation will be concealed via sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. Allocation will occur after baseline assessments, Blinding description: Participants will be blinded to the interaction style (positive, negative, neutral), which is the main experimental variable. Outcome assessors and the statistician will also be blinded to group allocation. Treating clinicians won’t be blinded due to the nature of the intervention. N/A knee Osteoarthritis. Intervention 1: Intervention group: Group 1: Comprehensive exercise + clinician’s positive pre-exercise interaction Group. group1 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician positive interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Intervention 2: Intervention group: Group 2: Comprehensive exercise + clinician’s negative pre-exercise interaction Group. group 2 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician negative interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Intervention 3: Control group: Group 3: Comprehensive exercise + clinician’s neutral pre-exercise interaction Group. group 3 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician neutral interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Yes - There is a plan to make this available What will be shared: De-identified individual participant data (IPD), including primary outcomes measures (VAS and WOMAC), and secondary outcomes will be available upon formal request after study completion. Supporting documents such as the study protocol, statistical analysis plan, and consent forms may also be shared if necessary. When: Data will be available starting 1 month after publication of the final study results. To whom: Researchers affiliated with academic institutions, recognized research centers, and professionals in the orthopedic and rehabilitation industry may submit data access requests. Conditions: Data may only be used for research purposes and statistical analyses aligned with the original study objectives. Any secondary publication must cite the original source and obtain written approval from the research team. Where to obtain: Requests should be directed to Dr. Maryam Bagheri Mahmoudi, principal investigator of the study, via official university email: maryambagherimahmudi@khu.ac.ir How to obtain: Upon receiving a formal request, the research team will review it within two weeks. If approved, a data sharing agreement will be sent. Once signed, the data will be transferred through a secure platform. Comments:
public Maryam Bagheri Mahmoudi
Unit 1, Floor 7, No. 18, Danesh-Pajouhan Complex, opposite Gilas Garden, Yasaman Square, Daneshjoo Boulevard, Evin, Tehran
Tehran Iran (Islamic Republic of) 1984845497 +98 937 814 7398 maryambagherimahmoudi@gmail.com دانشگاه خوارزمی scientific Maryam Bagheri Mahmoudi
Unit 1, Floor 7, No. 18, Danesh-Pajouhan Complex, opposite Gilas Garden, Yasaman Square, Daneshjoo Boulevard, Evin, Tehran
Tehran Iran (Islamic Republic of) 1984845497 +98 937 814 7398 maryambagherimahmoudi@gmail.com دانشگاه خوارزمی Iran (Islamic Republic of) Men and women aged 40 years or older a clinical diagnosis of knee Osteoarthritis (defined as knee pain for >3 months, early morning stiffness, crepitus, bony tenderness and no palpable warmth) in at least one knee radiographic grade 2 or 3 scored by the Kellgren and Lawrence (KL) scale in at least one knee pain from 3 to 7 on the Numerical Pain Rating Scale (NPRS) in at least one knee in the last week fluent in Persian (written and spoken) 40 years no limit Both M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation Intervention group: Group 1: Comprehensive exercise + clinician’s positive pre-exercise interaction Group. group1 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician positive interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Intervention group: Group 2: Comprehensive exercise + clinician’s negative pre-exercise interaction Group. group 2 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician negative interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Control group: Group 3: Comprehensive exercise + clinician’s neutral pre-exercise interaction Group. group 3 will receive 6-week Comprehensive exercise program. Prior to the first session, each participant receives a one-time, group-specific clinician neutral interaction designed to influence expectations. The exercises are designed to rehabilitate the knee muscles and are delivered by trained clinicians. Communication during sessions remains neutral to avoid bias. Pain: Perceived average pain. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Numerical Pain Rating Scale (NPRS) is a valid and reliable in middle-aged adults with knee osteoarthritis. Participants will rate their average pain over the past week on an 11-point numeric scale ranging from: 0 = “No pain” and 10 = “Worst imaginable pain”. Following exercise therapy, a reduction of ≥1.5 points on the NPRS is considered clinically meaningful (MCID), with excellent test–retest reliability (ICC = 0.95) and strong construct validity (r ≥ 0.93) compared to other pain scales. Disability. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The persian version of the WOMAC index (The Western Ontario and McMaster Universities Arthritis Index ) is used to assess pain, stiffness and physical activity as a reliable tool (ICC=0.99). It included 24 items: 5 questions about pain, 2 about stiffness and 17 about the level of physical activity in daily life. The score using an ordinal Likert scale of possible answers (0=strongly agree to 4=totally disagree). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. MCID ≈ 5.3, and ICC ≥ 0.76 for WOMAC subscales. Treatment Expectations. Timepoint: Baseline (T0), post-clinician interaction (T0.1, manipulation check), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Treatment expectations regarding anticipated changes in pain will be assessed using a modified version of the Global Rating of Change (GROC) scale adapted for expectations. At baseline and immediately after the expectation modulation, participants will be asked: “After completing the assigned treatment, how much do you expect your pain to change?” Responses will be recorded on a 15-point scale, ranging from −7 (“much worse”) to 0 (“no change”) to +7 (“much better”). Electromyographic (EMG). Timepoint: Muscle activity Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Electromyographic (EMG) assessment of muscle activity will be performed using an 8-channel system. active surface electrodes, Double differential, preamplifier electrodes will be placed over the belly of the following muscles of the leading foot of the lower extremity as per the recommended guidelines. EMG data will be collected during the three step-up trials performed as part of the kinematic assessment, and the EMG signals will be synchronized with the motion capture system and collected at 1080 Hz.A standing calibration trial will be used to define joint centers and create a segment coordinate system. Markers’ trajectories will be low-pass filtered at 6 Hz. EMG signals will be DC corrected and then band-pass, rectified, and adjusted for baseline noise by subtracting the mean of the rectified signal during the quiet period from the rectified signal. EMG amplitude will be normalized to the maximal activity from the dynamic trials, with the highest activity used for normalization. Knee kinematics. Timepoint: Muscle activity Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: Knee kinematics will be quantified during a step-up task using a three-dimensional marker-based motion analysis system (Motion Analysis Corp., Santa Rosa, CA). The system comprises eight high-resolution digital cameras, configured within a calibrated laboratory environment. Kinematic data will be captured at a sampling frequency of 120 Hz. Reflective markers (30 mm in diameter) will be bilaterally positioned at the following anatomical landmarks: Pelvis (ASIS), Thigh, Knee, Shank, Ankle, and Foot. Participants will perform a step-up task onto a standardized platform (20 cm). The 3D position of each marker at a high sampling frequency (e.g., 100–200 Hz) will be recorded by the motion capture system. Joint angles will be calculated from the relative orientation of adjacent body segments using inverse kinematics. Kinsiophobia. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The Tampa Scale of Kinesiophobia (TSK) measures “fear of movement” or “kinesiophobia” in the patient. The total score on this scale is between, 17 to 68. For example, a score of 68 showed severe fear of movement, 37 indicates there is fear of movement and where 17 means no fear. It is translated and validated into Persian and has been reported (ICC test-retest = 0.86) (Cronbach’s Alpha was 0.796 in 17 items). The least clinically significant difference (MCD) is 0.18).also, in chronic pain cohorts suggest that a change of approximately ≥6 points on the TSK total score may correspond to a minimally important clinical improvement. Self-efficacy. Timepoint: Baseline (T0), post-intervention (T1, 6 weeks), follow-up (T2, 3 months). Method of measurement: The Persian version of the Pain Self-Efficacy Questionnaire (PSEQ) will be used to assess self-efficacy. The questionnaire has been found to be a valid and reliable (ICC= 0.92) measure of pain self-efficacy beliefs). The PSEQ is a 10-item questionnaire ranging from 0 to 60 to assess patients’ confidence about their ability to perform a range of activities despite pain. For example: “I can do most of the household chores (e.g., tidying up, washing dishes), despite the pain” and “I can gradually increase my activity level, despite the pain. Lower scores for the PSEQ indicate lower levels of confidence. The least clinically significant difference (MCD) is 5.5-8.5. Kharazmi University Approved 2025-03-05 Kharazmi University 13th Floor, Block A, Central Headquarters of the Ministry of Health and Medical Education, Simaye Iran Street, between South Felamak and Zarafshan Streets, Qods Town (West), Tehran, Iran Tehran Tehran Iran (Islamic Republic of)