Resistance Exercise in Severe Knee Osteoarthritis (RTOA)

October 28, 2024 updated by: José Casaña Granell, University of Valencia

Impact of Different Resistance Training Protocols on Pain in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Clinic Universitary Hospital of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Placebo
control, with no exercise
Other: Placebo
No exercise
Other Names:
  • Control
Experimental: 4 sets
4 sets of 10RM of knee extensions
Other: Resistance Exercise
10 Repetition Maximum (RM)
Experimental: 8 sets
8 sets of 10RM of knee extensions
Other: Resistance Exercise
10 Repetition Maximum (RM)
Experimental: 12 sets
12 sets of 10RM of knee extensions
Other: Resistance Exercise
10 Repetition Maximum (RM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)
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)
Pre-exercise (pre), immediate post exercise (post), and 10 min after exercise (post 10min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
pre-exercise
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
pre-exercise
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
pre-exercise
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.
pre-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

December 5, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OA-2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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