Knee Osteoarthritishome_ATRNCT03100890
In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
A study testing Preoperative training (hospital) and Preoperative training (home) in people with Knee Osteoarthritis, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Preoperative training (hospital) and Preoperative training (home)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2017to 1 Nov 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Preoperative training (hospital), Preoperative training (home)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative training (hospital)Other
Preoperative hospital training
Preoperative training (home)Other
Preoperative in-home training
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Non-active comparator |
| Balance-Proprioception (Hospital) | Active comparator | Preoperative training (hospital) Receives: Other: Preoperative training (hospital) |
| Balance-Proprioception (Home) | Experimental | Preoperative training (home) Receives: Other: Preoperative training (home) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Self-reported functionality assessment
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 degree
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
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 posted4 Apr 2017
- Study start12 Apr 2017
- Primary completion1 Oct 2018
- Study completion1 Nov 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
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Principal investigator, Jose María Blasco Igual, University of Valencia
- Investigators
- José M Blasco, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100890
- Sponsor's protocol ID
- PRE_ATR_home
- Acronym
- home_ATR
- Status last verified
- Nov 2022
- First submitted
- 29 Mar 2017
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
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
- In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03100890
- Acronym / sponsor ID
- home_ATR / PRE_ATR_home
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
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.
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 |
| Balance-Proprioception (Hospital) | Active comparator | Other: Preoperative training (hospital)Preoperative training (hospital) |
| Balance-Proprioception (Home) | Experimental | Other: Preoperative training (home)Preoperative training (home) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Preoperative training (hospital)Preoperative hospital training | Other | Balance-Proprioception (Hospital) |
| Preoperative training (home)Preoperative in-home training | Other | Balance-Proprioception (Home) |
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
Self-reported functionality assessment
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
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 29221471Blasco 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.
- Individual participant dataSharing planned: Undecided
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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.
José 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 Preoperative training (hospital) and Preoperative training (home) in people with Knee Osteoarthritis, 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 4 inclusion and 3 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 NCT03100890, 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.