Acute Effects of Strengthening Lower Limbs Operated by Total Knee Arthroplasty (AESLLKNEE)

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: Strengthening; Other: Conventional protocol

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46005
    • Laura López-Bueno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Strengthening of lower limbs; The participants of this group will carry out their training following the protocol described. The participants work with strength of lower limbs.	Other: Strengthening; Strengthening
ACTIVE_COMPARATOR: Conventional protocol; The participants of this group will carry out their rehabilitation following the conventional protocol.	Other: Conventional protocol; Conventional protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	Number of repetitions achieved in each day and exercise. REGISTRO DE....	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	Kinesiophobia will be evaluated (REPASAR) mainly through the Spanish version of the Kinesiophobia Tampa Scale in a selfrecorded manner.	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.	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).	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.	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.	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).	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.	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).	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.	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.	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)	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.	3 days

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 5, 2022
• Primary Completion (ACTUAL): July 15, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (ACTUAL): July 5, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ID0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No