Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.

Not Applicable

Recruiting

• Conditions: Prehabilitation; Knee Osteoarthritis; Hip Osteoarthritis; Physical Therapy Modalities

• Registration Number: NCT06721897
• Lead Sponsor: Irene María Lopera Pareja

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Study Start: 2025-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Lower limb functionality	Start of study, week 6, week 9 and week 24.	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.
Strength	Start of the study, week 6, week 9 and week 24 (end of the intervention)	1RM - Brizky's formula: Test to assess endurance in multi-joint exercises. The most common application of this test is to assess changes in muscle strength during training periods. A simple and cost-effective test that does not require expensive equipment, hence its high use. In the case of estimating 1RM in patients with OA, it will be calculated using the indirect Brzycki method in the contralateral (unaffected) limb. To do this, the patient must perform between 6-10 repetitions of each exercise to be assessed with a fixed load that is not very high (5kg). After obtaining the number of repetitions performed with that load, the Brzycki formula will be applied (lifted weight/(1.0278-(0.0278\*number of repetitions)) which will give us the value of 1 RM with the established load. In the event that the exercise to be performed cannot be done with a weight, a set of mini-bands of different resistances (expressed in kilograms) will be used with which this same test will be performed.
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.

Trial Locations

Locations (1)

Hospital Universitario Costa Del Sol; 🇪🇸 Marbella, Spain