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Completed

NCT Number: NCT06664905

Resistance Exercise in Severe Knee Osteoarthritis

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic Universitary Hospital of Valencia

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance Exercise

Other

10 Repetition Maximum (RM)

Placebo

Other

No exercise

Other names: Control

Primary outcomes

  1. Change in self-reported pain intensity

    Time frame: 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

  2. Change in pressure pain thresholds

    Time frame: 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 outcomes

  1. WOMAC questionaire

    Time frame: 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.

  2. Tampa Scale of Kinesiophobia (TSK 11)

    Time frame: pre-exercise

    Measure fear of movement and its score ranges from 11-44 with higher scores indicate an increasing degree of kinesiophobia

  3. Chronic Pain Self-Efficacy Scale

    Time frame: 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

  4. Pain Catastrophizing Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Impact of Different Resistance Training Protocols on Pain in Knee Osteoarthritis

Acronym: RTOA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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