Exercise Therapy in Combination With Central Nervous System-targeted Treatment for Osteoarthritis
NCT ID: NCT03681613
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
121 participants
INTERVENTIONAL
2019-01-07
2022-08-30
Brief Summary
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Detailed Description
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The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
The CNS-targeted treatment will consist of 12-week individualized and supervised sessions applied twice weekly. Each training session will last approximately 30 minutes and include three parts, which are further explained below: 1) discussion of the participant's knee pain experience from a pain neuroscience perspective, 2) graded SDT and 3) GMI training.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Exercise Therapy With CNS Treatment
NEMEX program combined with a CNS-focused protocol
NEMEX program combined with a CNS-focused protocol
The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
The CNS-targeted treatment will consist of 12-week individualized and supervised sessions applied once weekly. Each training session will last approximately 30 minutes and include three parts, which are further explained below: 1) discussion of the participant's knee pain experience from a pain neuroscience perspective, 2) graded SDT and 3) GMI training.
Exercise Therapy alone
NEMEX program alone
NEMEX program
The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
Interventions
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NEMEX program combined with a CNS-focused protocol
The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
The CNS-targeted treatment will consist of 12-week individualized and supervised sessions applied once weekly. Each training session will last approximately 30 minutes and include three parts, which are further explained below: 1) discussion of the participant's knee pain experience from a pain neuroscience perspective, 2) graded SDT and 3) GMI training.
NEMEX program
The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of KOA according to the EULAR classification criteria: adults aged \>40 years with usage-related knee pain, only short-lived (\<30min) morning stiffness, functional limitation (based on yes/no to the following question: Is your functional level reduced as compared to before your knee symptoms first started?) and one or more typical examination findings (crepitus, restricted movement, bony enlargement). The presence of this cluster correctly diagnosed 99% of cases with KOA.
Exclusion Criteria
* Previous knee replacement or any other lower limb surgery in the affected knee within the previous 3 months.
* Fracture of the affected extremity within the previous 6 months.
* Initiation of opioid analgesia or any form of injection (i.e. corticosteroid, hyaluronic acid, platelet-rich plasma) for knee pain within the previous 30 days.
* Physical impairments unrelated to the knee that would prevent safe participation in exercise.
* Any comorbidity that prevents from participating in the interventions (e.g.uncontrolled hypertension, moderate to high risk for cardiac complications)
* Any skin or medical condition preventing tactile stimulation on the knee.
* Inability to comprehend and complete study assessments or comply with study instructions (e.g. illiteracy, cognitive or visual impairments).
* Inability to a priori attend or complete the proposed course of intervention and follow-up schedule.
41 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Enrique Lluch Girbés
PhD Professor
Principal Investigators
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Enrique Lluch Girbés, PhD
Role: STUDY_DIRECTOR
University of Valencia
Søren Thorgaard Skou, PhD
Role: STUDY_CHAIR
University of Southern Denmark
Javier Peral Pérez, PhD student
Role: PRINCIPAL_INVESTIGATOR
University of Alcalá
Locations
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University of Valencia
Valencia, , Spain
Countries
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References
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Other Identifiers
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H1526892955402
Identifier Type: -
Identifier Source: org_study_id
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