Clinical trial NCT06721897: Effectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery.
Official title: Effectiveness of a Prehabilitation Program on Clinical, Functional and Psychological Variables in Candidates for Hip or Knee Arthroplasty Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prehabilitation
Knee Osteoarthritis
Hip Osteoarthritis
Physical Therapy Modalities
Keywords: prehabilitation
knee osteoarthritis
hip osteoarthritis
physiotherapy preoperative
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: University of Jaén
First posted: 2024-12-06
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measuring Quality of life
timeFrame: Start of the study and week 24
Secondary outcomes:
measure: Lower limb functionality
timeFrame: Start of study, week 6, week 9 and week 24
measure: Lower limb functionality
timeFrame: Start of study, week 6, week 9 and week 24.
measure: Strength
timeFrame: Start of study, week 6, week 9 and week 24 (end of intervention).
measure: Strength
timeFrame: Start of the study, week 6, week 9 and week 24 (end of the intervention)
measure: Level of perceived exertion
timeFrame: From the start of the prehabilitation program until 6 weeks (end of the prehabilitation program)
measure: Intensity of Pain
timeFrame: Start of the intervention, week 6, week 9 and week 24.
measure: Psychological aspects
timeFrame: Start of intervention, week 6 and week 24.
measure: Sleep Quality
timeFrame: Start of the intervention and week 24
measure: Analgesic consumption
timeFrame: Start and week 6.
measure: Therapeutic adherence
timeFrame: Start of the intervention and week 6.
measure: Treatment expectations and therapeutic satisfaction
timeFrame: 24/48 hours post-surgery
measure: Independent values
timeFrame: All were measured at the start of the intervention and at week 24.
measure: Independent Values: Weight
timeFrame: The start of the intervention, week 6, week 9 and at week 24.
measure: Independent Values: Height
timeFrame: The start of the intervention and at week 24.
measure: Independent Values: body mass index (BMI)
timeFrame: The start of the intervention, week 6, week 9 and at week 24.
measure: Independent Values: general analytical and biochemical parameters
timeFrame: The start of the intervention and at 24/48 hours after surgery
Other outcomes:
Locations:
city: Marbella
country: Spain
facility: Hospital Universitario Costa Del Sol
Study officials:
affiliation: University of Jaen
name: IRENE MARIA IMLP LOPERA PAREJA, PRINCIPAL INVESTIGATOR
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Jaen
name: IRENE MARIA IM LOPERA, Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.