Tokyo, July 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059936) titled 'Online Acceptance and Commitment Therapy Combined with Exercise for Patellofemoral Pain Syndrome' on July 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Iran National Science Foundation (INSF)

Condition: Condition - Patellofemoral Pain Syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this randomized controlled trial is to determine whether an online-delivered Acceptance and Commitment Therapy (ACT) program, when combined with a structured exercise protocol, leads to greater improvements in pain intensity compared with exercise alone in patients with Patellofemoral Pain Syndrome. This objective focuses on evaluating whether the addition of ACT enhances the clinical effectiveness of exercise-based rehabilitation by addressing psychological factors - such as pain catastrophizing, fear of movement, and maladaptive beliefs - that often contribute to pain persistence and poorer functional outcomes in this population. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The ACT-based mindfulness protocol follows Gardner and Moore's seven-module model and is delivered twice weekly in 50-minute sessions by a trained sport psychology PhD student. It teaches mindfulness, acceptance, cognitive defusion, values clarification, and committed action to improve coping, reduce negative thoughts, and support rehabilitation in patients with PFPS. Interventions/Control_2 - All participants complete an 8-week supervised program of 17 exercises performed three times weekly for 60 to 90 minutes. Sessions include warm-up, strengthening at approximately 75 percent 10RM, and individualized load progression. Running is modified based on pain less than or equal to 3 of 10, with weekly treadmill feedback. Programs are continuously adjusted to symptoms.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Adults 18 to 45 with unilateral or bilateral patellofemoral pain for 3 months or more.

KOS-ADLS score less than 85 of 100.

Pain 3 of 10 or higher (VAS) during at least three functional activities.

No severe psychiatric disorders or psychoactive medication use.

Ability and willingness to engage in ACT and mindfulness. Key exclusion criteria - Intra-articular knee injuries, previous knee surgery, or hip pathology.

Patellar instability or tendon or joint line pain.

Osgood-Schlatter or Sinding-Larsen-Johansson syndrome.

Neurological, vestibular, or musculoskeletal conditions affecting participation.

Post-randomization: missing assessments, significant mood deterioration, or need for additional therapy or medication. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 01 Day Date of IRB - 2025 Year 12 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 02 Day Last follow-up date - 2026 Year 05 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068538

Disclaimer: Curated by HT Syndication.