PrehabilitationPreoperativeNCT06721897
Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.
A study testing Prehabilitation Program and Non prehabilitation Program in people with Prehabilitation and Knee Osteoarthritis, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Prehabilitation, Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Prehabilitation Program and Non prehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2025to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cognitive deficit/Dementia states
- Cancer processes
- Associated vascular and inflammatory pathologies
- Associated neurological pathologies
- Contraindications to physical exercise
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario San Cecilio- Distrito Sanitario Metropolitano Granada
Granada, 18012
About this study
Official title: Effectiveness of a Prehabilitation Program on Clinical, Functional and Psychological Variables in Candidates for Hip or Knee Arthroplasty Surgery.
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.
- Being tested
- Prehabilitation Program, Non prehabilitation Program
- Keywords
- prehabilitation, knee osteoarthritis, hip osteoarthritis, physiotherapy preoperative
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramOther
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.
Non prehabilitation ProgramOther
Also called Control Group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prehabilitation Program |
| 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. Receives: Other: Non prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Start of the study and week 24
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24/48 hours post-surgery
Independent values
Age and sex
Measured: All were measured at the start of the intervention and at week 24.
Independent Values: Weight
Weight (Kilograms)
Measured: The start of the intervention, week 6, week 9 and at week 24.
Independent Values: Height
Height (Metre)
Measured: The start of the intervention and at week 24.
Independent Values: body mass index (BMI)
body mass index (BMI) (kg/m2).
Measured: 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.
Measured: The start of the intervention and at 24/48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio
- Responsible party
- Principal investigator, Irene María Lopera Pareja, University of Jaén
- Investigators
- IRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR, Principal investigator, University of JaenIRENE MARIA IM LOPERA, Investigator, Principal investigator, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721897
- Sponsor's protocol ID
- 003_sep24 - PI2 - Prehabilitac
- Acronym
- Preoperative
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan for Sharing IPD from a Clinical Trial: 1. Objective: Promote transparency, reproducibility, and new knowledge generation while safeguarding participant confidentiality. 2. Ethical and legal aspects: Verify informed consent, de-identify data, and comply with regulations (e.g., GDPR, HIPAA). 3. Preparation: Review and anonymize data, accompanied by key documentation (data dictionary, protocol, CSR). 4. Infrastructure: Use secure platforms (e.g., Vivli, ClinicalStudyDataRequest) with access controls and traceability. 5. Access: Review requests based on clear criteria; require data use agreements (DUA) and ethical commitment from researchers. 6. Timeline: Share data 6-12 months after publication, available for 5-10 years. 7. Oversight: Monitor requests and compliance; assess impact and adjust the plan based on feedback.
Publications
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.
PubMed 38192160Franz 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.
PubMed 35774280Swank 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.
PubMed 21217530McKay 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.
PubMed 22698852Vitaloni 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.
PubMed 31656197Nguyen 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.
PubMed 35262716Dong 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.
PubMed 37641050Jahic 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.
PubMed 30814777das 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.
PubMed 29424236Chao 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.
PubMed 32037857Bennell 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.
PubMed 32200051Pedersen 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.
PubMed 26606383Koffel 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.
PubMed 31529104Alghadir 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.
PubMed 30967128Gao 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.
PubMed 36780435