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

Knee Osteoarthritis Clinical Trial

— home_ATR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100890
• Other study ID #: PRE_ATR_home
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: November 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Preoperative training (hospital)
Preoperative hospital training
• Preoperative training (home)
Preoperative in-home training

Locations

Country	Name	City	State
Spain	University of Valencia	Valence

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Hospital Politècnic i Universitari la Fe de València

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Self-reported functionality assessment	change from baseline to the week before surgery, 2 and 6 weeks after surgery
Primary	Berg Balance Scale (BBS)	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	change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary	Timed Up and Go Test (TUG)	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	change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary	Knee Range of Mobility (ROM)	Knee Range of Mobility (Flexion, Extension) in degree	change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary	Quadriceps Strength	Electronic dynamometer in Newton	change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary	Euro Quality of Life 5 Dimension	Quality of Life assessment	change from baseline to the week before surgery, 2 and 6 weeks after surgery