Prehabilitation, Knee Osteoarthritis, Hip Osteoarthritis, Physical Therapy Modalities
Conditions
Keywords
prehabilitation, knee osteoarthritis, hip osteoarthritis, physiotherapy preoperative
Brief summary
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.
Interventions
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.
OTHERNon prehabilitation Program
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.
Sponsors
University of Jaén
Hospital Clinico Universitario San Cecilio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of hip OA stage I-III of the Tönnis classification or diagnosis of knee OA stage I-IV of the Ahlbäck classification * Patients requiring hip/knee arthroplasty surgery * Signed informed consent * Obtaining a score equal to or greater than 8 repetitions in the Sit to Stand test * Patients with the ability to walk without technical aids or in need of some help (up to two canes or a walker)
Exclusion criteria
* Cognitive deficit/Dementia states * Cancer processes * Associated vascular and inflammatory pathologies * Associated neurological pathologies * Contraindications to physical exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring Quality of life | Start of the study and week 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb functionality | Start of study, week 6, week 9 and week 24 | 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. |
| Strength | Start of study, week 6, week 9 and week 24 (end of intervention). | 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. |
| Level of perceived exertion | From the start of the prehabilitation program until 6 weeks (end of the prehabilitation program) | 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. |
| Intensity of Pain | Start of the intervention, week 6, week 9 and week 24. | 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. |
| Psychological aspects | Start of intervention, week 6 and week 24. | 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. |
| Sleep Quality | Start of the intervention and week 24 | 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). |
| Analgesic consumption | Start and week 6. | 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 |
| Therapeutic adherence | Start of the intervention and week 6. | 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. |
| Treatment expectations and therapeutic satisfaction | 24/48 hours post-surgery | 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. |
| Independent values | All were measured at the start of the intervention and at week 24. | Age and sex |
| Independent Values: Weight | The start of the intervention, week 6, week 9 and at week 24. | Weight (Kilograms) |
| Independent Values: Height | The start of the intervention and at week 24. | Height (Metre) |
| Independent Values: body mass index (BMI) | The start of the intervention, week 6, week 9 and at week 24. | body mass index (BMI) (kg/m2). |
| Independent Values: general analytical and biochemical parameters | The start of the intervention and at 24/48 hours after surgery | number of white blood cells and red blood cells, number of platelets, blood hemoglobin and hematocrit value in femtoliters. |
Countries
Spain
Contacts
CONTACTIRENE MARIA IMLP LOPERA, Investigator
CONTACTIRENE IMAGINO LOPERA, Principal Investigator
PRINCIPAL_INVESTIGATORIRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR
University of Jaen
PRINCIPAL_INVESTIGATORIRENE MARIA IM LOPERA, Investigator
University of Jaen
Outcome results
None listed