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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Preoperative training (hospital)
Preoperative training (home)
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control

Balance-Proprioception (Hospital)

Balance-Proprioception (Home)

Arm Description

Non-active comparator

Preoperative training (hospital)

Preoperative training (home)

Outcomes

Primary Outcome Measures

Knee injury and Osteoarthritis Outcome Score (KOOS)
Self-reported functionality assessment
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

Secondary Outcome Measures

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
Knee Range of Mobility (ROM)
Knee Range of Mobility (Flexion, Extension) in degree
Quadriceps Strength
Electronic dynamometer in Newton
Euro Quality of Life 5 Dimension
Quality of Life assessment

Full Information

First Posted
March 29, 2017
Last Updated
November 28, 2022
Sponsor
University of Valencia
Collaborators
Hospital Politècnic i Universitari la Fe de València
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1. Study Identification

Unique Protocol Identification Number
NCT03100890
Brief Title
In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
Acronym
home_ATR
Official Title
In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Hospital Politècnic i Universitari la Fe de València

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-active comparator
Arm Title
Balance-Proprioception (Hospital)
Arm Type
Active Comparator
Arm Description
Preoperative training (hospital)
Arm Title
Balance-Proprioception (Home)
Arm Type
Experimental
Arm Description
Preoperative training (home)
Intervention Type
Other
Intervention Name(s)
Preoperative training (hospital)
Intervention Description
Preoperative hospital training
Intervention Type
Other
Intervention Name(s)
Preoperative training (home)
Intervention Description
Preoperative in-home training
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
Self-reported functionality assessment
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Knee Range of Mobility (ROM)
Description
Knee Range of Mobility (Flexion, Extension) in degree
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Quadriceps Strength
Description
Electronic dynamometer in Newton
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery
Title
Euro Quality of Life 5 Dimension
Description
Quality of Life assessment
Time Frame
change from baseline to the week before surgery, 2 and 6 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José M Blasco, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia
City
Valence
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29221471
Citation
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.
Results Reference
derived

Learn more about this trial

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

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