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Clinical Trials/NCT05274932
NCT05274932CompletedNot Applicable

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 enrollmentStarted: March 21, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Placebo

Active Comparator

Knee extensions with 30% 1RM and no occlusion pressure.

Intervention: BFR resistance exercise (Other)

BFR at 40% AOP

Experimental

Knee extensions with 30% 1RM and BFR at 40% AOP.

Intervention: BFR resistance exercise (Other)

BFR at 80% AOP

Experimental

Knee extensions with 30% 1RM and BFR at 80% AOP.

Intervention: BFR resistance exercise (Other)

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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

José Casaña Granell

Head of the Physiotherapy Department

University of Valencia

Study Sites (1)

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