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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Preoperative training (hospital); Other: Preoperative training (home)

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valence, Spain, 46010
    • University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Non-active comparator
Active Comparator: Balance-Proprioception (Hospital); Preoperative training (hospital)	Other: Preoperative training (hospital); Preoperative hospital training
Experimental: Balance-Proprioception (Home); Preoperative training (home)	Other: Preoperative training (home); Preoperative in-home training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quadriceps Strength	Electronic dynamometer in Newton	change from baseline to the week before surgery, 2 and 6 weeks after surgery
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
Euro Quality of Life 5 Dimension	Quality of Life assessment	change from baseline to the week before surgery, 2 and 6 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Hospital Politècnic i Universitari la Fe de València
• Investigators: Principal Investigator: Jose M Blasco, PhD, University of Valencia

Publications and helpful links

General Publications

• Blasco JM, Igual-Camacho C, Roig-Casasus S. In-home versus hospital preoperative balance and proprioceptive training in patients undergoing TKR; rationale, design, and method of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Dec 8;18(1):518. doi: 10.1186/s12891-017-1887-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PRE_ATR_home

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No