We live in an increasingly aging society in which the incidence of osteoarticular diseases increases, among which osteoarthritis (OA) stands out. OA is a degenerative disorder of the different components of the joint leading to a progressive destruction of the same. The hip and knee being the most affected joints, OA presents multiple symptoms such as pain, stiffness and functional limitation, also causing psychological disorders such as anxiety, depression, quality of sleep and poor perception of quality of life. Conventional treatment is aimed at alleviating symptoms, but when conservative therapies fail in the more advanced stages of the disease, total joint replacement surgery or arthroplasty is the therapeutic option of choice. Strength physical exercise (PE) and aerobic training have been shown to be effective in OA, obtaining positive effects on the symptoms and on variables that deteriorate this disease. The concept of pre-habilitation or preoperative rehabilitation has been shown through other studies in different pathologies (cardiopulmonary and musculoskeletal) to have positive effects at a clinical and functional level, however, the planning of a pre-habilitation protocol in hip or knee arthroplasty is still controversial. The purpose of this study is to determine the effect that a prehabilitation program will produce and its possible usefulness in those subjects who are waiting for a hip or knee arthroplasty. It is expected to find favorable results that support this therapy when it comes to reducing postoperative recovery times, functional capacity and other psychological variables of interest. This powerful tool could represent a non-pharmacological and non-invasive therapy, as well as being useful and economical in the management of patients with OA in advanced stages.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
A prehabilitation programme supervised by a physiotherapist in a ward is proposed, with a frequency of 3 sessions/week on alternate days lasting 30-45 min/session, in addition to a daily physical exercise programme at home. The programme will consist of a warm-up, strength exercises with progressive loads, proprioception, balance, cardiovascular training aimed at functional work and a cool-down. The home programme will be complementary to the supervised programme, which will consist of daily sessions of 20-30 min of flexibility and proprioception exercises. The same prehabilitation protocol will be proposed for those patients awaiting total hip and knee replacement surgery.
The control group (CG) will carry out a post-operative physiotherapy program in addition to a home exercise program that will be shown by the physiotherapist before hospital discharge.
Hospital Universitario San Cecilio- Distrito Sanitario Metropolitano Granada
Granada, Spain
Measuring Quality of life
SF-12 Health Questionnaire: This is a valid instrument for measuring health-related quality of life (HRQoL). The SF-12 is a reduced version of the SF-36 questionnaire, consisting of a subset of 12 items from the SF-36, selected by multiple regression, including 1 or 2 items from each of the 8 domains of the SF-36. From the information obtained from these 12 items, the SF-12 physical and mental summary measures are obtained as the only assessments. The assessments vary between 0 (no quality of life) and 100 (maximum quality of life).
Time frame: Start of the study and week 24
Lower limb functionality
Time Up and Go Test: Evaluates functional capacity through walking and balance, as well as its probable disorders in an elderly subject. It consists of timing the time to perform the following test: get up from a chair and walk at a normal pace a distance of 3 meters, have the person turn around, walk back to the chair and sit down again (6 meters in total). This test has three levels of interpretation: normal/independent (if the subject takes less than 20 seconds), slight risk of falling (between 20-29 seconds) and high risk of falling or dependency (values greater than 30 seconds). If the patient requires technical aids, this must be indicated on the data sheet. Two attempts are made and the best time is chosen.
Time frame: Start of study, week 6, week 9 and week 24
Lower limb functionality
Sit to Stand Test: This consists of counting the number of repetitions that the person gets up and sits down in a chair for 30 seconds. To do this, the subject will be seated in the chair in a posture that allows him to place his feet flat on the floor and separated at the height of his hips, with his knees bent at just over 90º. He will be told that his arms will remain crossed in front of his chest during the test. If the subject cannot lift anything in this position, he will be allowed certain adaptations (hands on his legs or on technical aids) noting said adaptations together with the number of repetitions. Each age range and sex has variable intervals of number of repetitions, although scores below 8 indicate a high risk of falls in both sexes.
Time frame: Start of study, week 6, week 9 and week 24.
Strength
Manual dynamometer: A low-cost, noninvasive method for assessing muscle strength. It is performed using a portable pressure algometer "Pain Test FPN 100" (Wagner Instruments, USA). Three attempts are made, each separated by 30 seconds. The manual dynamometer is a valid and reliable tool for measuring muscle strength, with an ICC between moderate and high (0.55 and 0.85) depending on the muscle group evaluated.
Time frame: Start of study, week 6, week 9 and week 24 (end of intervention).
Strength
1RM - Brzycki and Wlday Formula: A test to evaluate endurance in multi-joint exercises. Its most common application is to assess changes in muscle strength during training. It is a simple and inexpensive test that does not require costly equipment. To estimate 1RM in patients with osteoarthritis, it will be calculated using the indirect Brzycki and Wlday method on the contralateral (unaffected) limb. For this, the patient must perform the maximum possible repetitions with a fixed, relatively light load (5 kg). If fewer than 10 repetitions are performed, the Brzycki formula will be applied (weight lifted / (1.0278 - (0.0278 \* number of repetitions))). If 10 or more repetitions are performed, the Wlday formula will be applied ((weight lifted \* 0.0333 \* repetitions to failure) + weight lifted)), which will give the 1RM value with the established load.
Time frame: Start of the study, week 6, week 9 and week 24 (end of the intervention)
Level of perceived exertion
Modified Borg scale: Adapted from the classic perceived exertion (RPE) scale, the modified Borg scale is used to measure dyspnea and the intensity of the entire exercise session. It has a gradation from 0 to 10, where 0 represents the absence of dyspnea/rest and 10 is the maximum degree of dyspnea/exertion, so that the subject can indicate the level of perceived exertion subjectively during the training session.
Time frame: From the start of the prehabilitation program until 6 weeks (end of the prehabilitation program)
Intensity of Pain
Numeric Pain Rating Scale- NPRS: This is a scale for assessing pain intensity in a unidimensional manner. This subjective scale consists of 11 items (0-10) where 0 corresponds to no pain and 10 to maximum pain, so that the user can communicate the level of pain he or she has or perceives while performing the task.
Time frame: Start of the intervention, week 6, week 9 and week 24.
Psychological aspects
Goldberg Anxiety and Depression Scale (GADS): It is a useful tool to guide towards the diagnosis of anxiety or depression (or both) in addition to discriminating and sizing the intensities of each of them. It is composed of 2 subscales (anxiety subscale and depression subscale) with nine questions each. In the anxiety subscale (questions 1-9) a minimum of 2 questions from the first four questions must be answered affirmatively in order to continue with the subscale. In the case of the depression subscale (questions 10-18) it is sufficient to answer affirmatively one question from questions 10-13 in order to proceed to answer the rest. The total score varies from 0-18 points so that for the anxiety subscale the cut-off points are 4 points or more and 2 or more points for the depression subscale, the maximum score being 9 points for each subscale.
Time frame: Start of intervention, week 6 and week 24.
Sleep Quality
Pittsburgh Scale: This is an instrument for assessing sleep quality. It is made up of 24 items (although only 19 are taken into account for obtaining data) divided into 7 dimensions. Each dimension has 4 values on a scale of 0 to 3. The total ICSP score is obtained from the sum of the 7 dimensions, which ranges from 0 to 21 points (the higher the score, the worse the sleep quality).
Time frame: Start of the intervention and week 24
Analgesic consumption
Analgesic consumption: An activity diary is used to mark the days of the week that drugs are taken for OA pain relief. Therefore, values are measured from 0-7 days/week
Time frame: Start and week 6.
Therapeutic adherence
Therapeutic adherence: continuous quantitative metric variable. It was collected through a registration sheet provided at the beginning of the trial. It recorded the days per week of physical activity (0-7 days/week) as well as the duration of daily physical activity, taking values of number of hours/week.
Time frame: Start of the intervention and week 6.
Treatment expectations and therapeutic satisfaction
Nottingham Health Profile: Self-administered questionnaire designed to measure health perception and assess the extent to which health problems affect daily life activities. It consists of two parts, the first consisting of 38 questions that explore 6 dimensions of health (energy, pain, physical mobility, emotional state, sleep and social isolation). The second part consists of 7 questions about the functional limitations that the health problem causes in seven situations of daily life (work, housework, social life, family life, sexual life, hobbies and free time). Each question is answered with a YES/NO. Scores range from 0 to 100 points, with 0 indicating that the subject does not suffer from any health problems and 100 indicating that he or she suffers from all of them.
Time frame: 24/48 hours post-surgery
Independent values
Age and sex
Time frame: All were measured at the start of the intervention and at week 24.
Independent Values: Weight
Weight (Kilograms)
Time frame: The start of the intervention, week 6, week 9 and at week 24.
Independent Values: Height
Height (Metre)
Time frame: The start of the intervention and at week 24.
Independent Values: body mass index (BMI)
body mass index (BMI) (kg/m2).
Time frame: The start of the intervention, week 6, week 9 and at week 24.
Independent Values: general analytical and biochemical parameters
number of white blood cells and red blood cells, number of platelets, blood hemoglobin and hematocrit value in femtoliters.
Time frame: The start of the intervention and at 24/48 hours after surgery
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