Clinical trial NCT03100890: In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
Official title: In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Politècnic i Universitari la Fe de València
First posted: 2017-04-04
Enrollment: 67
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
measure: Berg Balance Scale (BBS)
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary outcomes:
measure: Timed Up and Go Test (TUG)
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
measure: Knee Range of Mobility (ROM)
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
measure: Quadriceps Strength
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
measure: Euro Quality of Life 5 Dimension
timeFrame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Other outcomes:
Locations:
city: Valence
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: José M Blasco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.