Resistance Exercise in Severe Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06664905
• Lead Sponsor: University of Valencia

Brief Summary

This study aim to evaluate pain after different resistance training protocols (placebo, 4 sets of 10RM, 8 sets of 10 RM and 12 sets of 10RM) in patients with severe knee osteoarthritis.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-10
• Study First Submitted: 2023-04-14
• Primary Completion: 2023-05-10
• Study Completion: 2023-12-05
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• men and women at least 55 years old
• diagnosed with severe knee OA
• scheduled for unilateral Total Knee Arthroplasty (TKA) surgery

Exclusion Criteria

• pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (VAS) during daily activities)
• another hip or knee joint replacement in the previous year
• any medical condition in which exercise was contraindicated
• participated in exercise programs (>2 days/week, training at intensities of 10-15RM) in the 6 months prior to the study
• history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of study tasks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in self-reported pain intensity	Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)	Measure of knee pain intensity with the Visual Analogue Scale (0-100mm), with higher scores reflecting higher perceived pain intensity
Change in pressure pain thresholds	Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)	Measured with a mechanical algometer (Wagner Instruments, Greenwich, CT, USA) in three sites (vastus medialis of the affected limb, vastus medialis of the unaffected limb, and distal to the non-dominant arm lateral epicondyle)

Secondary Outcome Measures

Name	Time	Method
WOMAC questionaire	pre-exercise	A self-administered questionnaire for patients with hip or knee osteoarthritis. contain 24 items grouped into three dimensions: pain (5 items), stiffness (2 items) and physical function (17 items). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Tampa Scale of Kinesiophobia (TSK 11)	pre-exercise	Measure fear of movement and its score ranges from 11-44 with higher scores indicate an increasing degree of kinesiophobia
Chronic Pain Self-Efficacy Scale	pre-exercise	Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms management, physical functioning, and coping with symptomsmanagement, physical functioning, and coping with symptoms. A higher score suggests higher self-efficacy
Pain Catastrophizing Scale	pre-exercise	People are asked to indicate the degree to which they have certain thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness, with higher scores reflecting worse condition.

Trial Locations

Locations (1)

Clinic Universitary Hospital of Valencia; 🇪🇸 Valencia, Spain