Knee OsteoarthritisPRE_TKR_BLCNCT02995668
Effects of Specific Balance Training Prior TKR Surgery in the Early Postoperative Outcomes
A study testing Strength-Function and Balance-Proprioception in people with Knee Osteoarthritis and Aging, run by University of Valencia at 1 site in Spain.
Trial summary
Knee osteoarthritis is one of the most common pathologies in old people, and the leading cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility, functional impairment and proprioceptive deficit. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Aging
- What is being tested?
- Strength-Function and Balance-Proprioception
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 80.
- Subjects with severe knee osteoarthritis that have not been operated before.
- Patients will be operated with the same total replacement prosthesis and same surgical procedure.
- The score in Berg scale must be greater than 21, indicating a medium-low risk of falling.
- The score of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
- Once the informed consent is read and explained, patients must accept and agree to participate in the study.
Who cannot join
- Patient with morphological alterations hip or ankle (also knee).
- Patient with suspected deep vein thrombosis or post-surgical infection of the operated knee.
- Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
- Patient with vestibular pathology that could interfere with the results of the test of balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influencia de un Entrenamiento Preoperatorio de propiocepción y Equilibrio en Pacientes Con Artrosis Severa de Rodilla en Espera Para la intervención de Artroplastia Total
Knee osteoarthritis is one of the most common pathologies in old people, and the leading cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility, functional impairment and proprioceptive deficit. When conservative treatments fail to control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly because of its efficacy on pain relief. In recent decades, this surgical procedure has been soared, and it has also aroused the interest of researches about the patients' outcomes after surgery.
Despite the TKR results in good reported outcomes, after surgery patients may manifest persistent pain and problems affecting to their functionality, stability, walking speed, proprioception, motor control, risk of falling and therefore to their quality of life. In more than a third of the cases, those deficiencies may be extended after surgery from six months to one year, when subjects use to achieve the plateau functional values.
Read more
Traditional rehabilitation programs have been usually focused on improving muscle strength of the lower limbs as well as the functionality with specific exercises to achieve this purpose, and to a lesser extent on balance and proprioception exercises. Evidence supports this approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the most important factors for a complete rehabilitation, since benefits of proprioceptive and balance trainings may range from better stability and motor control, improvements in both static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that the combination of traditional functional rehabilitation together with balance training may help to restore functional deficits to a larger extent than usual therapy, and based on a systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016), sensori-motor training is an acceptable adjust to usual physiotherapy care .
Looking into the effect of preoperative trainings or education before TKR surgery, it is aimed at improving the physical function, but also managing the expectations of the surgery for a better recovery. There is from low to moderate evidence about the effects of TKR pre-interventional training programs, and some authors have argued that the effects are too small to be consider clinically relevant.
In general, the preoperative program is usually focused on functional and strengthening exercises. Despite of proprioception is used in the clinical practice for the prevention and recovery of many orthopedics injuries, the amount of evidence about the effects of proprioceptive training programs for knee and hip replacement is not large, few works compares pre-habilitation and post-rehabilitation programs, and there is not systematically reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional training programs.
In this framework, this aimed at evaluating the effects of specific-task oriented proprioceptive and balance training programs when conducted by patients undergoing TKR before and after surgery, and will compare these effects to the outcomes achieved with traditional strength-functional programs, as well as to no specific prehabilitation training.
- Conditions
- Knee Osteoarthritis, Aging
- Being tested
- Strength-Function, Balance-Proprioception
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength-FunctionOther
Preoperative functional and strength capabilities training.
Balance-ProprioceptionOther
Preoperative proprioceptive and balance capabilities training
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Non-active comparator |
| Strength-Function | Active comparator | Active comparator Receives: Other: Strength-Function |
| Balance-Proprioception | Experimental | Experimental Receives: Other: Strength-Function; Other: Balance-Proprioception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
http://www.koos.nu/KOOSusersguide2012.pdf
Measured: change from baseline to the week before surgery, 2 and 6 weeks after surgery
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
Measured: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Secondary outcomes (4)
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
Measured: 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 degrees
Measured: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Quadriceps Strength
Electronic dynamometer in Newton
Measured: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Euro Quality of Life 5 Dimension (Euro-QoL-5D)
Quality of Life assessment
Measured: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study start17 Jan 2017
- Primary completion18 Sep 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
- Investigators
- Jose M Blasco, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995668
- Sponsor's protocol ID
- PRE_ATR_BALANCE
- Acronym
- PRE_TKR_BLC
- Status last verified
- Nov 2022
- First submitted
- 11 Dec 2016
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dominguez-Navarro F, Silvestre-Munoz A, Igual-Camacho C, Diaz-Diaz B, Torrella JV, Rodrigo J, Paya-Rubio A, Roig-Casasus S, Blasco JM. A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):838-848. doi: 10.1007/s00167-020-06029-x. Epub 2020 Apr 27.
PubMed 32342139
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencia de un Entrenamiento Preoperatorio de propiocepción y Equilibrio en Pacientes Con Artrosis Severa de Rodilla en Espera Para la intervención de Artroplastia Total
- ClinicalTrials.gov ID
- NCT02995668
- Acronym / sponsor ID
- PRE_TKR_BLC / PRE_ATR_BALANCE
- Conditions
- Knee Osteoarthritis, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis is one of the most common pathologies in old people, and the leading cause of pain and disability. Symptoms include joint pain, stiffness, limited mobility, functional impairment and proprioceptive deficit. When conservative treatments fail to control these symptoms, a total knee replacement (TKR) is the chosen treatment, mainly because of its efficacy on pain relief. In recent decades, this surgical procedure has been soared, and it has also aroused the interest of researches about the patients' outcomes after surgery.
Despite the TKR results in good reported outcomes, after surgery patients may manifest persistent pain and problems affecting to their functionality, stability, walking speed, proprioception, motor control, risk of falling and therefore to their quality of life. In more than a third of the cases, those deficiencies may be extended after surgery from six months to one year, when subjects use to achieve the plateau functional values.
Traditional rehabilitation programs have been usually focused on improving muscle strength of the lower limbs as well as the functionality with specific exercises to achieve this purpose, and to a lesser extent on balance and proprioception exercises. Evidence supports this approach. Yet, task-oriented rehabilitation focusing on balance enhancement may be one of the most important factors for a complete rehabilitation, since benefits of proprioceptive and balance trainings may range from better stability and motor control, improvements in both static and dynamic balance and enhanced functionality. Indeed, recent studies have shown that the combination of traditional functional rehabilitation together with balance training may help to restore functional deficits to a larger extent than usual therapy, and based on a systematic review published (Moutzori, 2015) and in our previous works (Roig, 2016), sensori-motor training is an acceptable adjust to usual physiotherapy care .
Looking into the effect of preoperative trainings or education before TKR surgery, it is aimed at improving the physical function, but also managing the expectations of the surgery for a better recovery. There is from low to moderate evidence about the effects of TKR pre-interventional training programs, and some authors have argued that the effects are too small to be consider clinically relevant.
In general, the preoperative program is usually focused on functional and strengthening exercises. Despite of proprioception is used in the clinical practice for the prevention and recovery of many orthopedics injuries, the amount of evidence about the effects of proprioceptive training programs for knee and hip replacement is not large, few works compares pre-habilitation and post-rehabilitation programs, and there is not systematically reviewed evidence reporting the efficacy of balance and proprioceptive pre-interventional training programs.
In this framework, this aimed at evaluating the effects of specific-task oriented proprioceptive and balance training programs when conducted by patients undergoing TKR before and after surgery, and will compare these effects to the outcomes achieved with traditional strength-functional programs, as well as to no specific prehabilitation training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Non-active comparator |
| Strength-Function | Active comparator | Other: Strength-FunctionActive comparator |
| Balance-Proprioception | Experimental | Other: Strength-Function, Other: Balance-ProprioceptionExperimental |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 60 and 80.
- Subjects with severe knee osteoarthritis that have not been operated before.
- Patients will be operated with the same total replacement prosthesis and same surgical procedure.
- The score in Berg scale must be greater than 21, indicating a medium-low risk of falling.
- The score of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
Key exclusion criteria (4 listed)
- Patient with morphological alterations hip or ankle (also knee).
- Patient with suspected deep vein thrombosis or post-surgical infection of the operated knee.
- Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
- Patient with vestibular pathology that could interfere with the results of the test of balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength-FunctionPreoperative functional and strength capabilities training. | Other | Balance-Proprioception, Strength-Function |
| Balance-ProprioceptionPreoperative proprioceptive and balance capabilities training | Other | Balance-Proprioception |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
http://www.koos.nu/KOOSusersguide2012.pdf
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
4 secondary outcomes
Timed Up and Go Test (TUG)
Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Knee Range of Mobility (ROM)
Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Quadriceps Strength
Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Euro Quality of Life 5 Dimension (Euro-QoL-5D)
Time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 32342139Dominguez-Navarro F, Silvestre-Munoz A, Igual-Camacho C, Diaz-Diaz B, Torrella JV, Rodrigo J, Paya-Rubio A, Roig-Casasus S, Blasco JM. A randomized controlled trial assessing the effects of preoperative strengthening plus balance training on balance and functional outcome up to 1 year following total knee replacement. Knee Surg Sports Traumatol Arthrosc. 2021 Mar;29(3):838-848. doi: 10.1007/s00167-020-06029-x. Epub 2020 Apr 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Blasco, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength-Function and Balance-Proprioception in people with Knee Osteoarthritis and Aging, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: change from baseline to the week before surgery, 2 and 6 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.