Total Knee ArthroplastyAESLLKNEENCT05444400
Acute Effects of Strengthening Lower Limbs Operated by Total Knee Arthroplasty
A study testing Strengthening and Conventional protocol in people with Total Knee Arthroplasty, run by University of Valencia at 1 site in Spain.
Trial summary
Knee osteoarthritis is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness.The purpose of the study is to evaluate the acute responses of lower limb strengthening… Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Strengthening and Conventional protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jul 2022to 15 Jul 2022
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 55 years of age.
- Total knee arthroplasty
- Intervention date in 2022, and who begin their physiotherapy treatment between days 1-2 post-surgical.
Who cannot join
- Participants have any involvement in the contralateral lower limb.
- Participants have already had/have any other knee injury or other anatomical part of the intervened LM (in the last year).
- Participants have any other condition or disease in which there is a contraindication to physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Strengthening the Lower Limbs on Physical Function and Pain in Patients Operated on by Total Knee Arthroplasty
Knee osteoarthritis is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness.The purpose of the study is to evaluate the acute responses of lower limb strengthening on physical function and pain, in patients operated on by total knee arthroplasty.Candidates for this study will be men and women over 55 years of age who have undergone total knee arthroplasty, who are admitted to the University Clinical Hospital of Valencia, with an intervention date in 2022-2023, and who begin their physiotherapy treatment between days 1-2 post-surgical.
Read the detailed description
Knee osteoarthritis (OA) is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness. Knee osteoarthritis often makes it difficult to participate in activities of daily living, which can make work difficult or even impossible, especially when it comes to physical activities that impose a great mechanical strain on the knee. For example, when climbing stairs, the pressure on the knees is six times greater than body weight, which is a known risk factor for knee OA due to occupational activities.Given the increasing prevalence of knee OA with the ageing population and the increasing state retirement age in most European countries, the implications of knee OA need to receive special attention.The most common surgical solution is the placement of a total knee arthroplasty, There are several reasons why your doctor might recommend knee replacement surgery. Recommendations for surgery are based on the patient's pain and disability, not age. Most patients who undergo a total knee replacement are between the ages of 55 and 80, but orthopedic surgeons evaluate patients individually. Usually, the surgical procedure takes between 1 and 2 hours. The orthopedic surgeon will remove the damaged cartilage and bone, and then place the new metal and/or plastic implants to restore knee alignment and function.The purpose of the study is to evaluate the acute responses of lower limb strengthening on physical function and pain, in patients operated on by total knee arthroplasty. Candidates for this study will be men and women over 55 years of age who have undergone total knee arthroplasty, who are admitted to the University Clinical Hospital of Valencia, with an intervention date in 2022-2023, and who begin their physiotherapy treatment between days 1-2 post-surgical. Patients will voluntarily participate in the study. All of them will be informed about the objectives and content of the research and written informed consent will be obtained. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.Participants will be excluded if they have any involvement in the contralateral lower limb, if they have already had/have any other knee injury or other anatomical part of the intervened MI (in the last year), and if they have any other condition or disease in which there is a contraindication to physical exercise. Also if they participate in other research studies. In addition, if severe neural or vascular injury is evident.In a previous study, initial WOMAC scores had a standard deviation of 11. If the difference between the means of the intervention and control groups is at least 10, a sample size of 20 patients in each group is adequate to reject the null hypothesis with a power of 80% and a significance level of p < 0.05.If possible, two days before the surgical intervention, a video will be sent to the participants with the performance of the exercises to be performed, so that they can check the technique to be executed. Likewise, they will be sent the following information about guidelines to follow for the realization of the tests:
- Try to rest at least 8 hours the post-surgical night. Patients will be treated while admitted to the hospital (between 3 and 4 days), through 1 session / day of approximately 40 minutes.
Evaluation 1 will be performed on the first day after surgery (1st postoperative day) and evaluation 2 on the day of hospital discharge (3rd postoperative day).EXERCISE PROGRAM WITH ELASTIC RESISTANCE:
- All exercises are done until the maximum number of repetitions is reached, since they will only be done once / day.
- During the first day, each exercise should begin with 2 sets of 2 repetitions as a warm-up and calculation of the appropriate intensity. The appropriate intensity will be the one where the patient tells us that he perceives 5-6 out of 10 on the Borg CR10 scale after finishing 2 repetitions.CONTROL GROUP EXERCISE PROGRAM:
The patients of the control group will perform the physiotherapy exercises following the RHB protocol in ATR of the University Clinical Hospital of Valencia.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Strengthening, Conventional protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrengtheningOther
Strengthening
Conventional protocolOther
Conventional protocol
| Study group | Role | What they receive |
|---|---|---|
| Strengthening of lower limbs | Experimental | The participants of this group will carry out their training following the protocol described. The participants work with strength of lower limbs. Receives: Other: Strengthening |
| Conventional protocol | Active comparator | The participants of this group will carry out their rehabilitation following the conventional protocol. Receives: Other: Conventional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
Number of repetitions achieved in each day and exercise. REGISTRO DE....
Measured: 3 days
Secondary outcomes (12)
Kinesiophobia
Kinesiophobia will be evaluated (REPASAR) mainly through the Spanish version of the Kinesiophobia Tampa Scale in a selfrecorded manner.
Measured: 3 days
Pain intensity
The patient will be mark a point on the scale and subsequently, the clinician or researcher quantifies the number of mm indicated by the patient. The level is from 0 to 100 mm.
Measured: 3 days
Pain percepcion
The chronic pain perception will be measured by Questionnaire on Perception of Self-Efficacy in the Face of Chronic Pain (CPSS) that contains 19 items and evaluates 3 domains: self-efficacy for pain management (α=0.72), physical functioning (α=0.98) and symptom management (α=0.85).
Measured: 3 days
Range of motion
The degrees of movement (ROM) of the following joints shall be actively and passively measured by means of a manual goniometer.
Measured: 3 days
Isometric knee extension/flexion force
They will be evaluated with a portable handheld dynamometer.maximum contractions of 5 seconds will be performed, separated by 1 minute of rest, selecting the average value of these 3 for later analysis.
Measured: 3 days
Self-administered physical function
WOMAC questionnaire be used to assess stiffness, pain and physical function in a self-administered manner. The questionnaire is a multidimensional scale composed of 24 items divided into 3 domains: functional pain (5 items), stiffness (2 items) and difficulties in activities of daily living (17 items).
Measured: 3 days
Catastrophism
Scale of Catastrophism before pain in a self-registered way, which consists of 13 items that describe different thoughts and feelings associated with pain. The scale has 5 degrees, being 0 nothing at all, 1 a little, 2 moderately, 3 a lot and 4 all the time. The subject must mark his situation in each case. The scale consists of 13 items in total (0-52 points). Higher scores will indicate higher levels of pain catastrophism.
Measured: 3 days
Perceived change
From the beginning of the study (first day after the operation), my general physical condition will be measure by Patients Global Impression Change (PGIC). The level is from 1 (I have improved a lot) to 7 (I have gotten a lot worse).
Measured: 3 days
Gait functionality
The Time up and go (TUG) measures the time it takes for a person to get up from a standard chair (without using their arms to get up), walk to a line on the floor 3m away, turn around, walk back to the chair, and sit down again. Walking aids (e.g. walker) are allowed if necessary. Two tests are performed, with one minute of rest between them, using the highest value for analysis.
Measured: 3 days
Spillage from the knee joint
It was assessed by measuring knee circumference. Patients lie on a stretcher with the operated knee relaxed and extended as much as possible. If the knee can extend below 0°, a cylinder is placed under the heel. A non-elastic tape measure was carefully placed and adjusted 1 cm above the base of the kneecap. Knee joint circumference was measured twice and the highest value was used for analysis.
Measured: 3 days
Pressure pain thresholds
UDP is defined as the minimum amount of pressure in which a feeling of pressure is transformed into a sensation of pain. The mechanical pressure instrument, called an algometer (Wagner Instruments, Greenwich, CT, USA), will be used in this study. This consists of a round rubber disc (1 cm2 in surface) attached to a pressure (force)
Measured: 3 days
Use of analgesics
we assessed the number of days on which participants were taking painkillers during the week. The following question was asked of the participants: "As a result of the pain, how many days during this week did you take painkillers?" Participants had to respond with a number of 0-7, and the drugs administered were recorded in the hospitalization room.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start5 Jul 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
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 Total Knee ArthroplastyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura López-Bueno, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444400
- Sponsor's protocol ID
- ID0003
- Acronym
- AESLLKNEE
- Status last verified
- Nov 2022
- First submitted
- 21 Jun 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nunez-Cortes R, Lopez-Bueno L, Lopez-Bueno R, Cuenca-Martinez F, Suso-Marti L, Silvestre A, Casana J, Cruz-Montecinos C, Andersen LL, Calatayud J. Acute Effects of In-Hospital Resistance Training on Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 May 1;103(5):401-409. doi: 10.1097/PHM.0000000000002366. Epub 2023 Nov 22.
PubMed 38063321
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Strengthening the Lower Limbs on Physical Function and Pain in Patients Operated on by Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05444400
- Acronym / sponsor ID
- AESLLKNEE / ID0003
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Jul 2022 (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.
Knee osteoarthritis is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness.The purpose of the study is to evaluate the acute responses of lower limb strengthening on physical function and pain, in patients operated on by total knee arthroplasty.Candidates for this study will be men and women over 55 years of age who have undergone total knee arthroplasty, who are admitted to the University Clinical Hospital of Valencia, with an intervention date in 2022-2023, and who begin their physiotherapy treatment between days 1-2 post-surgical.
Detailed description
Knee osteoarthritis (OA) is a chronic joint disease and one of the leading causes of disability among adults, resulting in irreversible damage to articular cartilage and subchondral bone, osteophyte formation, joint pain and stiffness. Knee osteoarthritis often makes it difficult to participate in activities of daily living, which can make work difficult or even impossible, especially when it comes to physical activities that impose a great mechanical strain on the knee. For example, when climbing stairs, the pressure on the knees is six times greater than body weight, which is a known risk factor for knee OA due to occupational activities.Given the increasing prevalence of knee OA with the ageing population and the increasing state retirement age in most European countries, the implications of knee OA need to receive special attention.The most common surgical solution is the placement of a total knee arthroplasty, There are several reasons why your doctor might recommend knee replacement surgery. Recommendations for surgery are based on the patient's pain and disability, not age. Most patients who undergo a total knee replacement are between the ages of 55 and 80, but orthopedic surgeons evaluate patients individually. Usually, the surgical procedure takes between 1 and 2 hours. The orthopedic surgeon will remove the damaged cartilage and bone, and then place the new metal and/or plastic implants to restore knee alignment and function.The purpose of the study is to evaluate the acute responses of lower limb strengthening on physical function and pain, in patients operated on by total knee arthroplasty. Candidates for this study will be men and women over 55 years of age who have undergone total knee arthroplasty, who are admitted to the University Clinical Hospital of Valencia, with an intervention date in 2022-2023, and who begin their physiotherapy treatment between days 1-2 post-surgical. Patients will voluntarily participate in the study. All of them will be informed about the objectives and content of the research and written informed consent will be obtained. The study will conform to the Declaration of Helsinki and will be approved by the local ethics committee.Participants will be excluded if they have any involvement in the contralateral lower limb, if they have already had/have any other knee injury or other anatomical part of the intervened MI (in the last year), and if they have any other condition or disease in which there is a contraindication to physical exercise. Also if they participate in other research studies. In addition, if severe neural or vascular injury is evident.In a previous study, initial WOMAC scores had a standard deviation of 11. If the difference between the means of the intervention and control groups is at least 10, a sample size of 20 patients in each group is adequate to reject the null hypothesis with a power of 80% and a significance level of p < 0.05.If possible, two days before the surgical intervention, a video will be sent to the participants with the performance of the exercises to be performed, so that they can check the technique to be executed. Likewise, they will be sent the following information about guidelines to follow for the realization of the tests:
- Try to rest at least 8 hours the post-surgical night. Patients will be treated while admitted to the hospital (between 3 and 4 days), through 1 session / day of approximately 40 minutes.
Evaluation 1 will be performed on the first day after surgery (1st postoperative day) and evaluation 2 on the day of hospital discharge (3rd postoperative day).EXERCISE PROGRAM WITH ELASTIC RESISTANCE:
- All exercises are done until the maximum number of repetitions is reached, since they will only be done once / day.
- During the first day, each exercise should begin with 2 sets of 2 repetitions as a warm-up and calculation of the appropriate intensity. The appropriate intensity will be the one where the patient tells us that he perceives 5-6 out of 10 on the Borg CR10 scale after finishing 2 repetitions.CONTROL GROUP EXERCISE PROGRAM:
The patients of the control group will perform the physiotherapy exercises following the RHB protocol in ATR of the University Clinical Hospital of Valencia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening of lower limbs | Experimental | Other: StrengtheningThe participants of this group will carry out their training following the protocol described. The participants work with strength of lower limbs. |
| Conventional protocol | Active comparator | Other: Conventional protocolThe participants of this group will carry out their rehabilitation following the conventional protocol. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over 55 years of age.
- Total knee arthroplasty
- Intervention date in 2022, and who begin their physiotherapy treatment between days 1-2 post-surgical.
Key exclusion criteria (3 listed)
- Participants have any involvement in the contralateral lower limb.
- Participants have already had/have any other knee injury or other anatomical part of the intervened LM (in the last year).
- Participants have any other condition or disease in which there is a contraindication to physical exercise.
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 |
|---|---|---|
| StrengtheningStrengthening | Other | Strengthening of lower limbs |
| Conventional protocolConventional protocol | Other | Conventional protocol |
Primary outcome
Strength
Time frame: 3 days
Number of repetitions achieved in each day and exercise. REGISTRO DE....
12 secondary outcomes
Kinesiophobia
Time frame: 3 days
Pain intensity
Time frame: 3 days
Pain percepcion
Time frame: 3 days
Range of motion
Time frame: 3 days
Isometric knee extension/flexion force
Time frame: 3 days
Self-administered physical function
Time frame: 3 days
Catastrophism
Time frame: 3 days
Perceived change
Time frame: 3 days
Gait functionality
Time frame: 3 days
Spillage from the knee joint
Time frame: 3 days
Pressure pain thresholds
Time frame: 3 days
Use of analgesics
Time frame: 3 days
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 8 Nov 2022.
- Derived from this study: PubMed 38063321Nunez-Cortes R, Lopez-Bueno L, Lopez-Bueno R, Cuenca-Martinez F, Suso-Marti L, Silvestre A, Casana J, Cruz-Montecinos C, Andersen LL, Calatayud J. Acute Effects of In-Hospital Resistance Training on Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 May 1;103(5):401-409. doi: 10.1097/PHM.0000000000002366. Epub 2023 Nov 22.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening and Conventional protocol in people with Total Knee Arthroplasty, 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 3 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 8 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?
Strength (time frame: 3 days). 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 NCT05444400, 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 8 Nov 2022.