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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Spain1 site
  • Laura López-Bueno

    Valencia, 46005

Other trials in Spain

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.

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 groups in NCT05444400
Study groupRoleWhat they receive
Strengthening of lower limbsExperimentalThe 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 protocolActive comparatorThe 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.

  1. Strength

    Number of repetitions achieved in each day and exercise. REGISTRO DE....

    Measured: 3 days

Secondary outcomes (12)
  1. Kinesiophobia

    Kinesiophobia will be evaluated (REPASAR) mainly through the Spanish version of the Kinesiophobia Tampa Scale in a selfrecorded manner.

    Measured: 3 days

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted5 Jul 2022
  2. Study start5 Jul 2022
  3. Primary completion15 Jul 2022
  4. Study completion15 Jul 2022

Resources

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)
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

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.

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