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CompletedNCT03100890home_ATRUpdated Nov 29, 2022

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

An interventional study of Preoperative training (hospital) and Preoperative training (home) in Knee Osteoarthritis, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

  • Knee Osteoarthritis
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In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 67 is close to the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University of Valencia is the lead sponsor of 355 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • No intervention
    Control

    Non-active comparator

  • Active comparator
    Balance-Proprioception (Hospital)

    Preoperative training (hospital)

    Other: Preoperative training (hospital)

  • Experimental
    Balance-Proprioception (Home)

    Preoperative training (home)

    Other: Preoperative training (home)

Interventions

  • OtherPreoperative training (hospital)

    Preoperative hospital training

  • OtherPreoperative training (home)

    Preoperative in-home training

06

What researchers measure

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Self-reported functionality assessment

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  2. 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

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

Secondary outcomes

  1. 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

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  2. Knee Range of Mobility (ROM)

    Knee Range of Mobility (Flexion, Extension) in degree

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  3. Quadriceps Strength

    Electronic dynamometer in Newton

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

  4. Euro Quality of Life 5 Dimension

    Quality of Life assessment

    Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery

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Study locations

1 site
  • University of Valencia
    Valencia, 46010, Spain
08

References and documents

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. PubMed 29221471 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03100890
Collaborators
Hospital Universitario La Fe
Responsible party
Jose María Blasco Igual (PhD, University of Valencia) — Principal investigator
First posted
Apr 4, 2017
Start date
Apr 12, 2017
Primary completion
Oct 1, 2018
Completion
Nov 1, 2019
Last update
Nov 29, 2022

Study contacts

José M Blasco, PhD
principal investigator · University of Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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