UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059936 |
|---|---|
| Receipt number | R000068538 |
| Scientific Title | Comparing the Effectiveness of Online-Delivered Acceptance and Commitment Therapy Combined with Exercise versus Exercise Alone on Pain, Function, and Psychological Beliefs in Patients with Patellofemoral Pain Syndrome: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/07/04 |
| Last modified on | 2025/12/01 21:30:08 |
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Basic information
Public title
Online Acceptance and Commitment Therapy Combined with Exercise for Patellofemoral Pain Syndrome
Acronym
ACT-PFPS
Scientific Title
Comparing the Effectiveness of Online-Delivered Acceptance and Commitment Therapy Combined with Exercise versus Exercise Alone on Pain, Function, and Psychological Beliefs in Patients with Patellofemoral Pain Syndrome: A Randomized Controlled Trial
Scientific Title:Acronym
Online ACT Combined with Exercise versus Exercise Alone in Patellofemoral Pain Syndrome (ACT-PFPS): A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Patellofemoral Pain Syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Intensity (VAS)
Knee-Related Function
Key secondary outcomes
Pain Catastrophizing (PCS)
Fear of Movement (TSK-17)
Coping Strategies (CSQ)
Psychological Flexibility (ACT-related processes)
Physical Activity Level
Patient Global Rating of Change (GROC)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | 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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport Scince
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
ay.naderi@shahroodut.ac.ir
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport science
Zip code
3619995161
Address
Shahrood, Iran
TEL
02332392204
Homepage URL
ay.naderi@shahodut.ac.ir
Sponsor or person
Institute
Iran National Science Foundation (INSF)
Institute
Department
Personal name
Funding Source
Organization
Iran National Science Foundation (INSF)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Physical Education
Address
Shahrood University of Technology
Tel
9177217462
ay.naderi@shahroodut.ac.ir
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068538
