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

NCT06721897 | Recruiting DMC

• 1 other identifier: 003_sep24 - PI2 - Prehabilitac
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation; Knee Osteoarthritis; Hip Osteoarthritis; Physical Therapy Modalities

Keywords

prehabilitation; knee osteoarthritis; hip osteoarthritis; physiotherapy preoperative

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Lower limb functionality

  Start of study, week 6, week 9 and week 24

• Lower limb functionality

  Start of study, week 6, week 9 and week 24.

• Strength

  Start of study, week 6, week 9 and week 24 (end of intervention).

• Strength

  Start of the study, week 6, week 9 and week 24 (end of the intervention)

• Level of perceived exertion

  From the start of the prehabilitation program until 6 weeks (end of the prehabilitation program)

Study Arms (2)

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.

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.

Other: Non prehabilitation Program

Interventions

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.

Intervention Group

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.

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cognitive deficit/Dementia states
• Cancer processes
• Associated vascular and inflammatory pathologies
• Associated neurological pathologies
• Contraindications to physical exercise

Sponsors & Collaborators

• University of Jaén: lead
• Hospital Clinico Universitario San Cecilio: collaborator

Study Sites (1)

Hospital Universitario San Cecilio- Distrito Sanitario Metropolitano Granada

Granada, 18012, Spain

RECRUITING

Related Publications (16)

• 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.

  PMID: 38192160 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.

  PMID: 35774280 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.

  PMID: 21217530 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.

  PMID: 22698852 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.

  PMID: 31656197 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.

  PMID: 35262716 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.

  PMID: 37641050 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.

  PMID: 30814777 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.

  PMID: 29424236 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.

  PMID: 32037857 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.

  PMID: 32200051 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.

  PMID: 26606383 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.

  PMID: 31529104 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.

  PMID: 30967128 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.

  PMID: 36780435 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.

  PMID: 31948193 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• IRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR

  University of Jaen

  PRINCIPAL INVESTIGATOR

• IRENE MARIA IM LOPERA, Investigator

  University of Jaen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IRENE MARIA IMLP LOPERA, Investigator

CONTACT

+34 664 656 871; ireneloperapareja@gmail.com

IRENE IMAGINO LOPERA, Principal Investigator

CONTACT

664656871; Ireneloperapareja@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 6, 2024
• Study Start: May 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: January 2025- January 2026
• 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.

Locations

ES (1)