NCT05444400

Brief Summary

Knee osteoarthritis is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness.The purpose of the study is to evaluate the acute responses of lower limb strengthening on physical function and pain, in patients operated on by total knee arthroplasty.Candidates for this study will be men and women over 55 years of age who have undergone total knee arthroplasty, who are admitted to the University Clinical Hospital of Valencia, with an intervention date in 2022-2023, and who begin their physiotherapy treatment between days 1-2 post-surgical.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

June 21, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

10 days

First QC Date

June 21, 2022

Last Update Submit

November 7, 2022

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Strength

    Number of repetitions achieved in each day and exercise. REGISTRO DE....

    3 days

Secondary Outcomes (12)

  • Kinesiophobia

    3 days

  • Pain intensity

    3 days

  • Pain percepcion

    3 days

  • Range of motion

    3 days

  • Isometric knee extension/flexion force

    3 days

  • +7 more secondary outcomes

Study Arms (2)

Strengthening of lower limbs

EXPERIMENTAL

The participants of this group will carry out their training following the protocol described. The participants work with strength of lower limbs.

Other: Strengthening

Conventional protocol

ACTIVE COMPARATOR

The participants of this group will carry out their rehabilitation following the conventional protocol.

Other: Conventional protocol

Interventions

StrengtheningOTHER

Strengthening

Strengthening of lower limbs
Conventional protocolOTHER

Conventional protocol

Conventional protocol

Eligibility Criteria

Age55 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over 55 years of age.
  • Total knee arthroplasty
  • Intervention date in 2022, and who begin their physiotherapy treatment between days 1-2 post-surgical.

You may not qualify if:

  • Participants have any involvement in the contralateral lower limb.
  • Participants have already had/have any other knee injury or other anatomical part of the intervened LM (in the last year).
  • Participants have any other condition or disease in which there is a contraindication to physical exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura López-Bueno

Valencia, 46005, Spain

Location

Related Publications (1)

  • Nunez-Cortes R, Lopez-Bueno L, Lopez-Bueno R, Cuenca-Martinez F, Suso-Marti L, Silvestre A, Casana J, Cruz-Montecinos C, Andersen LL, Calatayud J. Acute Effects of In-Hospital Resistance Training on Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 May 1;103(5):401-409. doi: 10.1097/PHM.0000000000002366. Epub 2023 Nov 22.

    PMID: 38063321DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Laura López-Bueno

Study Record Dates

First Submitted

June 21, 2022

First Posted

July 5, 2022

Study Start

July 5, 2022

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)