In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Preoperative training (hospital); Other: Preoperative training (home)

• Registration Number: NCT03100890
• Lead Sponsor: University of Valencia

Brief Summary

In this work the importance of the potentiation and recovery of the balance with a physiotherapeutic intervention that begins in the early preoperative phase is compared with the conventional postoperative rehabilitation. The objective is to evaluate the influence of a muscle enhancement protocol in which a specific work of balance is included, with the physical benefits that this entails for the evolution of the patient. It also seeks to verify if the teaching and recommendation of exercises at home as preparation and conditioning for the intervention of ATR is effective, and to what extent, compared to a guided training in the hospital.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Study Start: 2017-04-12
• Primary Completion: 2018-10-01
• Study Completion: 2019-11-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Subjects with severe knee osteoarthritis that have not been operated before of total knee replacement.
• The score in Berg scale must be greater than 21.
• The score of the Mini-Mental State Examination must be equal or greater than 20.
• Once the informed consent is read and explained, patients must accept and agree to participate in the study.

Exclusion Criteria

• Post-surgical infection of the operated knee.
• Pathology of central origin (i.e. cerebellar) that could interfere with balance or strength
• Vestibular pathology that could interfere with balance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance-Proprioception (Hospital)	Preoperative training (hospital)	Preoperative training (hospital)
Balance-Proprioception (Home)	Preoperative training (home)	Preoperative training (home)

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score (KOOS)	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Self-reported functionality assessment
Berg Balance Scale (BBS)	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Overall state of balance. Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test

Secondary Outcome Measures

Name	Time	Method
Quadriceps Strength	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Electronic dynamometer in Newton
Timed Up and Go Test (TUG)	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Dynamic balance assessment. Also points at the risk of falling. Time of getting up from a chair, walk three meters, come back and sit again, measured in seconds
Knee Range of Mobility (ROM)	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Knee Range of Mobility (Flexion, Extension) in degree
Euro Quality of Life 5 Dimension	change from baseline to the week before surgery, 2 and 6 weeks after surgery	Quality of Life assessment

Trial Locations

Locations (1)

University of Valencia; 🇪🇸 Valence, Spain