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| Name | Class |
|---|---|
| Hospital Clinico Universitario San Cecilio | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group (IG) will undergo a 6-week prehabilitation program for total hip/knee replacement surgery. Once the surgery is complete, they will follow the same rehabilitation program proposed for the control group. |
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| Control Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Start of the study and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| IRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR | University of Jaen | Principal Investigator |
| IRENE MARIA IM LOPERA, Investigator | University of Jaen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario San Cecilio- Distrito Sanitario Metropolitano Granada | Granada | 18012 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38192160 | Background | Granicher P, Mulder L, Lenssen T, Fucentese SF, Swanenburg J, De Bie R, Scherr J. Exercise- and education-based prehabilitation before total knee arthroplasty: a pilot study. J Rehabil Med. 2024 Jan 8;56:jrm18326. doi: 10.2340/jrm.v56.18326. | |
| 35774280 | Background | Franz A, Ji S, Bittersohl B, Zilkens C, Behringer M. Impact of a Six-Week Prehabilitation With Blood-Flow Restriction Training on Pre- and Postoperative Skeletal Muscle Mass and Strength in Patients Receiving Primary Total Knee Arthroplasty. Front Physiol. 2022 Jun 14;13:881484. doi: 10.3389/fphys.2022.881484. eCollection 2022. |
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Plan for Sharing IPD from a Clinical Trial:
January 2025- January 2026
Access Criteria for IPD Sharing:
Research Purpose: Access is granted solely for valid scientific research that aligns with the objectives of the original study or advances medical knowledge.
Application Requirements: Applicants must submit a detailed research proposal, including objectives, methodology, and justification for using the requested data.
Researcher Qualifications: Access is limited to qualified researchers affiliated with recognized institutions.
Data Use Agreement (DUA): Applicants must sign a DUA, agreeing to use the data only for the approved purpose, maintain confidentiality, and avoid re-identification of participants.
Ethical Compliance: The research must have ethics committee approval and comply with relevant legal and regulatory standards.
Transparency: Researchers must commit to publishing results in peer-reviewed journals or other scientific forums.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 26, 2024 | Feb 11, 2026 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Non prehabilitation Program | Other | 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. |
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| 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 90ยบ. 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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 | 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. | 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. | 24/48 hours post-surgery |
| Independent values | Age and sex | All were measured at the start of the intervention and at week 24. |
| Independent Values: Weight | Weight (Kilograms) | The start of the intervention, week 6, week 9 and at week 24. |
| Independent Values: Height | Height (Metre) | The start of the intervention and at week 24. |
| Independent Values: body mass index (BMI) | body mass index (BMI) (kg/m2). | 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. | The start of the intervention and at 24/48 hours after surgery |
| 21217530 | Background | Swank AM, Kachelman JB, Bibeau W, Quesada PM, Nyland J, Malkani A, Topp RV. Prehabilitation before total knee arthroplasty increases strength and function in older adults with severe osteoarthritis. J Strength Cond Res. 2011 Feb;25(2):318-25. doi: 10.1519/JSC.0b013e318202e431. |
| 22698852 | Background | McKay C, Prapavessis H, Doherty T. The effect of a prehabilitation exercise program on quadriceps strength for patients undergoing total knee arthroplasty: a randomized controlled pilot study. PM R. 2012 Sep;4(9):647-56. doi: 10.1016/j.pmrj.2012.04.012. Epub 2012 Jun 13. |
| 31656197 | Background | Vitaloni M, Botto-van Bemden A, Sciortino Contreras RM, Scotton D, Bibas M, Quintero M, Monfort J, Carne X, de Abajo F, Oswald E, Cabot MR, Matucci M, du Souich P, Moller I, Eakin G, Verges J. Global management of patients with knee osteoarthritis begins with quality of life assessment: a systematic review. BMC Musculoskelet Disord. 2019 Oct 27;20(1):493. doi: 10.1186/s12891-019-2895-3. |
| 35262716 | Background | Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462. |
| 37641050 | Background | Dong Y, Yan Y, Zhou J, Zhou Q, Wei H. Evidence on risk factors for knee osteoarthritis in middle-older aged: a systematic review and meta analysis. J Orthop Surg Res. 2023 Aug 29;18(1):634. doi: 10.1186/s13018-023-04089-6. |
| 30814777 | Background | Jahic D, Omerovic D, Tanovic AT, Dzankovic F, Campara MT. The Effect of Prehabilitation on Postoperative Outcome in Patients Following Primary Total Knee Arthroplasty. Med Arch. 2018 Dec;72(6):439-443. doi: 10.5455/medarh.2018.72.439-443. |
| 29424236 | Background | das Nair R, Mhizha-Murira JR, Anderson P, Carpenter H, Clarke S, Groves S, Leighton P, Scammell BE, Topcu G, Walsh DA, Lincoln NB. Home-based pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): a feasibility randomized controlled trial. Clin Rehabil. 2018 Jun;32(6):777-789. doi: 10.1177/0269215518755426. Epub 2018 Feb 9. |
| 32037857 | Background | Chao J, Jing Z, Xuehua B, Peilei Y, Qi G. Effect of Systematic Exercise Rehabilitation on Patients With Knee Osteoarthritis: A Randomized Controlled Trial. Cartilage. 2021 Dec;13(1_suppl):1734S-1740S. doi: 10.1177/1947603520903443. Epub 2020 Feb 10. |
| 32200051 | Background | Bennell KL, Nelligan RK, Kimp AJ, Schwartz S, Kasza J, Wrigley TV, Metcalf B, Hodges PW, Hinman RS. What type of exercise is most effective for people with knee osteoarthritis and co-morbid obesity?: The TARGET randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):755-765. doi: 10.1016/j.joca.2020.02.838. Epub 2020 Mar 19. |
| 26606383 | Background | Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581. |
| 31529104 | Background | Koffel E, Kats AM, Kroenke K, Bair MJ, Gravely A, DeRonne B, Donaldson MT, Goldsmith ES, Noorbaloochi S, Krebs EE. Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial. Pain Med. 2020 Jun 1;21(6):1162-1167. doi: 10.1093/pm/pnz221. |
| 30967128 | Background | Alghadir AH, Anwer S, Sarkar B, Paul AK, Anwar D. Effect of 6-week retro or forward walking program on pain, functional disability, quadriceps muscle strength, and performance in individuals with knee osteoarthritis: a randomized controlled trial (retro-walking trial). BMC Musculoskelet Disord. 2019 Apr 9;20(1):159. doi: 10.1186/s12891-019-2537-9. |
| 36780435 | Background | Gao B, Li L, Shen P, Zhou Z, Xu P, Sun W, Zhang C, Song Q. Effects of proprioceptive neuromuscular facilitation stretching in relieving pain and balancing knee loading during stepping over obstacles among older adults with knee osteoarthritis: A randomized controlled trial. PLoS One. 2023 Feb 13;18(2):e0280941. doi: 10.1371/journal.pone.0280941. eCollection 2023. |
| 31948193 | Background | Ughi N, Prevete I, Ramonda R, Cavagna L, Filippou G, Manara M, Bortoluzzi A, Parisi S, Ariani A, Scire CA. The Italian Society of Rheumatology clinical practice guidelines for the diagnosis and management of gout. Reumatismo. 2019 Sep 23;71(S1):50-79. doi: 10.4081/reumatismo.2019.1176. |
| D012216 |
| Rheumatic Diseases |
| D008722 | Methods |