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OpenTrials
Completed

NCT Number: NCT03100890

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

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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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative training (hospital)

Other

Preoperative hospital training

Preoperative training (home)

Other

Preoperative in-home training

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

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

    Self-reported functionality assessment

  2. Berg Balance Scale (BBS)

    Time frame: 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 outcomes

  1. Timed Up and Go Test (TUG)

    Time frame: 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

  2. Knee Range of Mobility (ROM)

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

    Knee Range of Mobility (Flexion, Extension) in degree

  3. Quadriceps Strength

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

    Electronic dynamometer in Newton

  4. Euro Quality of Life 5 Dimension

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

    Quality of Life assessment

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital Universitario La Fe

Registry information

Acronym: home_ATR

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 4, 2017
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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