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

February 11, 2026 updated by: Irene María Lopera Pareja, University of Jaén

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Granada, Spain, 18012
        • Recruiting
        • Hospital Universitario San Cecilio- Distrito Sanitario Metropolitano Granada
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Other: Prehabilitation Program

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.
Experimental: 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.
Other: Non 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.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring Quality of life
Time Frame: 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).
Start of the study and week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limb functionality
Time Frame: 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.
Start of study, week 6, week 9 and week 24
Lower limb functionality
Time Frame: 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.
Start of study, week 6, week 9 and week 24.
Strength
Time Frame: 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.
Start of study, week 6, week 9 and week 24 (end of intervention).
Level of perceived exertion
Time Frame: 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.
From the start of the prehabilitation program until 6 weeks (end of the prehabilitation program)
Intensity of Pain
Time Frame: 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.
Start of the intervention, week 6, week 9 and week 24.
Psychological aspects
Time Frame: 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.
Start of intervention, week 6 and week 24.
Sleep Quality
Time Frame: 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).
Start of the intervention and week 24
Analgesic consumption
Time Frame: 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
Start and week 6.
Therapeutic adherence
Time Frame: 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.
Start of the intervention and week 6.
Treatment expectations and therapeutic satisfaction
Time Frame: 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.
24/48 hours post-surgery
Independent values
Time Frame: All were measured at the start of the intervention and at week 24.
Age and sex
All were measured at the start of the intervention and at week 24.
Independent Values: Weight
Time Frame: The start of the intervention, week 6, week 9 and at week 24.
Weight (Kilograms)
The start of the intervention, week 6, week 9 and at week 24.
Independent Values: Height
Time Frame: The start of the intervention and at week 24.
Height (Metre)
The start of the intervention and at week 24.
Independent Values: body mass index (BMI)
Time Frame: The start of the intervention, week 6, week 9 and at week 24.
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
Time Frame: 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.
The start of the intervention and at 24/48 hours after surgery
Strength
Time Frame: Start of the study, week 6, week 9 and week 24 (end of the intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jaén

Collaborators

Hospital Clinico Universitario San Cecilio

Investigators

  • Principal Investigator: IRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR, University of Jaén
  • Principal Investigator: IRENE MARIA IM LOPERA, Investigator, University of Jaén

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 003_sep24 - PI2 - Prehabilitac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

January 2025- January 2026

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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