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Clinical Trials/NCT05274932
NCT05274932
Completed
N/A

Neuromuscular Responses, Pain Intensity and Perceived Exertion of Resistance Exercise With Blood Flow Restriction in Patients With Severe Knee Osteoarthritis

University of Valencia1 site in 1 country22 target enrollmentMarch 21, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of Valencia
Enrollment
22
Locations
1
Primary Endpoint
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the neuromuscular responses, pain intensity and rate of perceived exertion in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with blood flow restriction at different levels of arterial occlusion pressure.

Registry
clinicaltrials.gov
Start Date
March 21, 2022
End Date
May 20, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

José Casaña Granell

Head of the Physiotherapy Department

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • men and women above 55 years old.
  • diagnosed with severe knee osteoarthritis.
  • scheduled for unilateral TKA surgery in a local hospital during 2021- 2022.

Exclusion Criteria

  • pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a 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 dual tasks.

Outcomes

Primary Outcomes

Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)

Time Frame: Pre exercise, immediate post set, immediate post session, and 10 minutes after session.

Change from baseline to the end of the session, and the change between the treatment group and the placebo group.

HDsEMG

Time Frame: During each experimental session and during each exercise condition.

Change between baseline and exercise, and the change between the treatment group and the placebo group.

Pressure pain thresholds

Time Frame: Pre exercise, immediate post session, and 10 minutes after session.

Change from baseline to the end of the session, and the change between the treatment group and the placebo group.

Secondary Outcomes

  • Tampa Scale of Kinesiophobia (TSK 11)(Pre session.)
  • Chronic Pain Self-Efficacy Scale (CPSS)(Pre session.)
  • Pain Catastrophizing Scale (PCS)(Pre session.)
  • Heart Rate(Pre exercise, immediate post set, immediate post session, and 10 minutes after session.)
  • WOMAC questionaire for patients with hip or knee osteoarthritis.(Pre session.)
  • Rating of perceived exertion (RPE) based on Borg's CR10 scale(Immediate post exercise.)

Study Sites (1)

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