Resistance Exercise in Severe Knee Osteoarthritis
RTOA
Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Apr 2023
Shorter than P25 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2023
CompletedFirst Submitted
Initial submission to the registry
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 30, 2024
CompletedOctober 30, 2024
October 1, 2024
1 month
April 14, 2023
October 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in self-reported pain intensity
Measure of knee pain intensity with the Visual Analogue Scale (0-100mm), with higher scores reflecting higher perceived pain intensity
Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Change in pressure pain thresholds
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)
Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
Secondary Outcomes (4)
WOMAC questionaire
pre-exercise
Tampa Scale of Kinesiophobia (TSK 11)
pre-exercise
Chronic Pain Self-Efficacy Scale
pre-exercise
Pain Catastrophizing Scale
pre-exercise
Study Arms (4)
Placebo
ACTIVE COMPARATORcontrol, with no exercise
4 sets
EXPERIMENTAL4 sets of 10RM of knee extensions
8 sets
EXPERIMENTAL8 sets of 10RM of knee extensions
12 sets
EXPERIMENTAL12 sets of 10RM of knee extensions
Interventions
Eligibility Criteria
You may qualify if:
- men and women at least 55 years old
- diagnosed with severe knee OA
- scheduled for unilateral Total Knee Arthroplasty (TKA) surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic Universitary Hospital of Valencia
Valencia, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Physiotherapy Department
Study Record Dates
First Submitted
April 14, 2023
First Posted
October 30, 2024
Study Start
April 10, 2023
Primary Completion
May 10, 2023
Study Completion
December 5, 2023
Last Updated
October 30, 2024
Record last verified: 2024-10