NCT05274932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

March 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

February 15, 2022

Last Update Submit

May 23, 2022

Conditions

Knee Osteoarthritis

Keywords

Knee OsteoarthritisElectromyographyMuscle ActivityResistance Training

Outcome Measures

Primary Outcomes (3)

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

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

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

  • Pressure pain thresholds

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

    Pre exercise, immediate post session, and 10 minutes after session.

  • HDsEMG

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

    During each experimental session and during each exercise condition.

Secondary Outcomes (6)

  • Tampa Scale of Kinesiophobia (TSK 11)

    Pre session.

  • Pain Catastrophizing Scale (PCS)

    Pre session.

  • Chronic Pain Self-Efficacy Scale (CPSS)

    Pre session.

  • WOMAC questionaire for patients with hip or knee osteoarthritis.

    Pre session.

  • Heart Rate

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

  • +1 more secondary outcomes

Study Arms (3)

Placebo

ACTIVE COMPARATOR

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

Other: BFR resistance exercise

BFR at 40% AOP

EXPERIMENTAL

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

Other: BFR resistance exercise

BFR at 80% AOP

EXPERIMENTAL

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

Other: BFR resistance exercise

Interventions

BFR resistance exerciseOTHER

4 sets (30, 15, 15, 15 reps).

BFR at 40% AOPBFR at 80% AOPPlacebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic Universitary Hospital of Valencia

Valencia, 46010, Spain

Location

Related Publications (1)

  • Ogrezeanu DC, Lopez-Bueno L, Sanchis-Sanchez E, Carrasco JJ, Cuenca-Martinez F, Suso-Marti L, Lopez-Bueno R, Cruz-Montecinos C, Martinez-Valdes E, Casana J, Calatayud J. Neuromuscular Responses and Perceptions of Health Status and Pain-Related Constructs in End-Stage Knee Osteoarthritis During Resistance Training With Blood Flow Restriction. J Strength Cond Res. 2024 Apr 1;38(4):762-772. doi: 10.1519/JSC.0000000000004680. Epub 2023 Dec 13.

    PMID: 38090743DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • José Casaña

    University of Valencia

    PRINCIPAL INVESTIGATOR

  • Joaquín Calatayud

    University of Valencia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Physiotherapy Department

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 11, 2022

Study Start

March 21, 2022

Primary Completion

May 13, 2022

Study Completion

May 20, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)