Acute Effects of Strengthening Lower Limbs Operated by Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional

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 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.
    

Intervention name(s): Strengthening; Conventional protocol
Intervention type(s): Other; Other
Intervention description(s): Strengthening; Conventional protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment