Effekten af terapeutisk træning på bruskmorfologi og fysisk funktion for personer med høj risiko for knæartrose
Effekten af progressive modstandsøvelser versus aerobe øvelser på bruskmorfologi og fysisk funktion hos patienter med degenerativ meniskrivning: et randomiseret kontrolleret forsøg
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Baggrund: Degenerative menisker er almindelige hos personer over 35 og er forbundet med tidlige stadier af knæartrose (OA) (1,2). Metaboliske og mikrostrukturelle ændringer i brusken sker før overfladenedbrydning, som nu kan påvises ved hjælp af avancerede MR-teknikker såsom T2-kortlægning. Træningsterapi, specifikt progressiv modstand og aerobe øvelser, har vist fordele for patienter med knæ-OA, men dens virkninger på tidlig bruskdegeneration er dårligt forstået.
Formål: Det primære formål med denne undersøgelse er at bestemme effektiviteten af PRE og aerobe øvelser på den metaboliske funktion og mikrostruktur af brusk hos personer med degenerative meniskrifter, men uden radiografisk tegn på knæ-OA. Sekundære mål inkluderer evaluering af virkningen af disse øvelser på kliniske resultater, såsom smerte, handicap og fysisk funktion, og vurdering af gennemførligheden af rekruttering og fastholdelse til et større forsøg.
Metoder: Undersøgelsen vil inkludere 54 deltagere, som vil blive randomiseret i tre grupper: PRE, aerob træning og kontrol. Hver gruppe vil gennemgå et 3-måneders superviseret træningsprogram. MR-scanninger vil blive brugt til at måle ændringer i brusksammensætning, mens kliniske resultater vil blive vurderet ved hjælp af patientrapporterede og præstationsbaserede mål.
Interventionsgrupper:
Gruppe 1 (PRE): Deltagerne vil udføre progressive modstandsøvelser med fokus på at styrke quadriceps. Øvelserne vil blive justeret baseret på Daily Adjustable Progressive Resistance Exercise (DAPRE) teknikken.
Gruppe 2 (Aerob træning): Deltagerne vil deltage i aerobe træningssessioner ved hjælp af en stationær cykel, med det formål at forbedre kardiovaskulær kondition og knæledsmobilitet.
Gruppe 3 (Kontrol): Deltagerne vil modtage standardbehandling, inklusive generelle styrke- og balanceøvelser i henhold til gældende kliniske retningslinjer.
Vurderinger:
MR-billeddannelse: Avancerede MR-teknikker (T2-kortlægning) vil blive brugt ved baseline og efter 3 måneder til at vurdere ændringer i brusksammensætning.
Kliniske resultater: Patientrapporterede resultater vil omfatte resultaterne for knæskade og slidgigt (KOOS) og den internationale knædokumentationskomité (IKDC). Præstationsbaserede resultater vil omfatte enkeltbens squat, single-ben hop test, sidde-til-stå på en en-fods test, step-up test og Bruce løbebåndstest.
Inklusionskriterier:
Voksne i alderen 35-55 år Symptomatisk degenerative mediale menisk tårer. Ingen røntgenologiske tegn på knæ-OA (Kellgren-Lawrence grad 0-1). Evne til at give informeret samtykke. Lyst til at deltage i øvelsesinterventionen.
Ekskluderingskriterier:
Eksisterende diagnose af knæ-OA (Kellgren-Lawrence grad 2 eller højere). Reparerbare meniskskader eller tidligere meniskreparation. Tidligere knæoperation eller betydelig knæskade inden for de seneste 6 måneder. Tilstedeværelse af inflammatorisk arthritis eller andre væsentlige følgesygdomme. Kontraindikationer til MR eller manglende evne til at deltage i træningsprogrammer.
Studieresultater:
Primære resultater: Ændringer i T2 afslapningstider i brusken, hvilket indikerer ændringer i brusksammensætning og sundhed.
Sekundære resultater: Forbedringer i kliniske resultater, herunder smerte, handicap og fysisk funktion målt ved KOOS, IKDC og præstationsbaserede tests.
Feasibility Metrics: Rekrutteringsrater, overholdelse af træningsprogrammet og fastholdelsesrater i løbet af studieperioden.
Analyse: En blandet ANOVA vil blive brugt til at sammenligne ændringer i resultater mellem grupper, med justeringer for flere sammenligninger. Baseline-karakteristika vil blive sammenlignet ved hjælp af t-test og chi-square test.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Ar Ramtha, Jordan
- Rekruttering
- King Abdullah University Hospital
-
Kontakt:
- Khaldoon Bashaireh, MD
- Telefonnummer: 0096227200600
- E-mail: bashaireh@just.edu.jo
-
Irbid, Jordan
- Rekruttering
- Jordan University of Science and Technology
-
Kontakt:
- Mohammad Yabroudi, PhD
- Telefonnummer: 26936 0096227201000
- E-mail: m.yabroudi@just.edu.jo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Er mellem 35 og 55 år.
Har en symptomatisk degenerativ medial meniskoverrivning, som det fremgår af:
- Tilstedeværelse af mediale knæsmerter.
- Ømhed i den mediale ledlinje.
- Smerter og begrænset bevægelse, når du forsøger at udføre en fuld squat og
- Øget intramenisk signal på mindst 2 på hinanden følgende MR-snit og
- Få tilladelse fra deres personlige læge til at deltage i et træningsprogram.
Ekskluderingskriterier:
- Radiografisk tegn på OA (K-L grad 2 eller derover).
- En reparerbar meniskskade (langsgående rift i den yderste 1/3 af menisken).
- En meniskskade, der kræver meniskektomi (låst knæ).
- Tidligere eller nuværende ledbåndsskade eller operation af det involverede knæ.
- Tidligere eller nuværende skade eller operation i kontralateralt knæ.
- Patologisk ligamentøs slaphed ved undersøgelse af knæet
- En inflammatorisk arthritisk tilstand eller
- Enhver skade eller tilstand, der involverer underekstremiteterne, som påvirker deres evne til at gå.
Fordi deltagelse i denne undersøgelse kræver at gennemgå MR, vil forsøgspersoner blive udelukket, hvis de:
- Hvis kvinde, gravid på tidspunktet for tilmelding.
- Havde forudgående operation for en aneurisme; enhver medicinsk sygdom, der kan forstyrre patientens generelle kondition eller træningsevne.
- Havde nogen kontraindikation med MR.
- Blev opereret inden for de sidste to måneder.
- Har en pacemaker.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Progressive Resistance Exercise (PRE)
Deltagerne vil udføre progressive modstandsøvelser med fokus på at styrke quadriceps musklerne.
Øvelserne vil blive justeret baseret på Daily Adjustable Progressive Resistance Exercise (DAPRE) teknikken.
|
Et struktureret træningsprogram med fokus på at øge muskelstyrke og udholdenhed gennem progressiv modstand.
Andre navne:
|
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Eksperimentel: Aerob træning
Deltagerne vil deltage i aerobe træningssessioner ved hjælp af en stationær cykel, rettet mod at forbedre kardiovaskulær kondition og knæledsmobilitet.
|
Et træningsprogram med fokus på kardiovaskulær konditionering ved hjælp af en stationær cykel.
Andre navne:
|
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Aktiv komparator: Styring
Deltagerne vil modtage standardbehandling, herunder generelle styrke- og balanceøvelser i henhold til gældende kliniske retningslinjer.
|
Et sæt generelle styrke- og balanceøvelser, der ikke er rettet mod de specifikke terapeutiske mål for de andre interventioner.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Short echo T2*
Tidsramme: Baseline, 3-month, 24-month, and 5 years follow-ups.
|
Short echo time T2* imaging is used to diagnose early cartilage degeneration.
T2* measures the rate at which the MRI signal decays, particularly focusing on short-T2 signals (less than 10 milliseconds) which decay rapidly (3-6).
|
Baseline, 3-month, 24-month, and 5 years follow-ups.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Single leg hop test for a distance
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The Single Leg Hop Test for distance is one of four assessments used to evaluate athletes' horizontal movement capabilities. These tests, collectively known as the 4 Single Leg Hop Tests, were established by Noyes et al (7). They include the Triple Hop for distance, the Single Leg Hop Test for distance, the 6-meter hop for time, and the Crossover Hop for distance. In the Single Leg Hop Test for distance, participants stand on one leg with their toes aligned along a designated landmark line. They then execute a forward hop, landing eccentrically while maintaining balance on the tested leg. The examiner measures the distance from the initial landmark line to the point where the participant's heel contacts the ground (8). This test is valuable for assessing lower extremity strength, power, and balance. It has been shown to be a reliable and valid measure for evaluating aspects of lower extremity function (9-10). |
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
|
Single Leg Squat Test
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The Single Leg Squat Test is a functional movement assessment used to evaluate lower extremity strength, neuromuscular control, and stability. Beyond its focus on lower limb function, it also helps identify core muscle strength and provides insights into an individual's capabilities in cutting, running, and landing (11). The SLST assesses the ability to alternate between concentric and eccentric contractions of the knee and hip muscles (12). In the test, the patient stands on one leg with their foot aligned with a straight line. The examiner assists with balance and ensures proper form. The patient then performs knee bends until the line along their toes is no longer visible, within a 30-degree range of knee flexion. Each patient has 30 seconds to complete as many repetitions as possible, with the maximum number recorded (13-16). The physiotherapist monitors and adjusts the test to maintain accuracy and consistency. |
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
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The Timed Stair Climbing Test (SCT)
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The Timed Stair Climbing Test (SCT) is a functional performance assessment designed to evaluate lower extremity strength, endurance, and functional mobility.
Participants will ascend and descend a 12-step staircase, with each step measuring 18 cm in height and 28 cm in depth.
The objective is to complete the test as quickly as possible while ensuring a sense of safety and comfort.
While the use of one handrail is optional, participants are encouraged to refrain from using it (17).
|
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
|
The Single Leg Chair Rise (SLCR) test
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The Single Leg Chair Rise (SLCR) test evaluates quadriceps strength and can also help diagnose mid-lumbar nerve root impingement and radiculopathy (18,19). It has a sensitivity of 0.48, a specificity of 0.90, a positive likelihood ratio of 4.60, and a negative likelihood ratio of 0.58 (19). The protocol uses a 45.7 cm chair. Participants, dressed and shod, sit with arms crossed, the tested leg flexed at 90 degrees, and the other leg extended without touching the ground. They rise to full knee extension and then return to the seated position to complete one repetition. The test includes two assessments: one measuring endurance with as many repetitions as possible in 30 seconds, and another measuring power by completing five repetitions as quickly as possible. Each test is performed twice, with the best score recorded (20). |
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
|
Maximal voluntary isometric contraction test
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
To assess quadriceps muscle strength, the maximum voluntary isometric torque test will be performed using an isokinetic dynamometer (Biodex System 3 Pro). The procedure involves the participant seated with their ankle positioned in line with the dynamometer's axis at 60 degrees of knee flexion, secured by waist, thigh, and chest straps (21). Before testing, participants will familiarize themselves with the process by performing isometric contractions at 50%, 75%, and 100% of their maximal effort. During the actual test, they will exert maximal force against the dynamometer's fixed arm for knee extension. Each participant will complete three trials with a two-minute rest between them, aiming to match or exceed a target torque displayed on a screen. The target torque will be adjusted based on their performance in previous trials. The maximum quadriceps muscle strength will be calculated using the recorded data (21). |
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
|
The Modified Bruce Treadmill Testing Protocol
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The modified Bruce Test is designed for sedentary and elderly patients to estimate maximal oxygen consumption (VO2max) and assess aerobic endurance. Unlike the standard Bruce Test, which includes seven stages of increasing speed and incline on a treadmill, the modified version starts with a lower workload. It begins at 1.7 km/hr with a 0% incline and progresses to a 5% incline in the second stage, before resembling the first stage of the standard test. This modified approach includes "Stage Zero" and "1/2" to indicate the initial zero incline and a slight incline in the following stage, making it more suitable for less fit individuals (22,23). VO2max measures the maximum amount of oxygen a person uses during intense exercise. It is calculated based on the duration of exercise using different formulas for men and women, without needing to measure inhaled and exhaled air directly (22,23): Women: VO2max (ml/kg/min) = 4.38 × T - 3.9 Men: VO2max (ml/kg/min) = 2.94 × T + 7.65 |
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
|
International Knee Documentation Committee Subjective Knee Form (IKDC)
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The International Knee Documentation Committee Subjective Knee Form (IKDC) was developed in 2001 through a collaboration between the European Society for Sports Traumatology, Knee Surgery, and Arthroscopy, and the American Orthopaedic Society for Sports Medicine (AOSSM).
This form is a widely used patient-reported outcome measure that assesses subjective aspects of a patient's health related to knee conditions.
It includes domains such as symptoms, functional limitations, and sports activities.
The IKDC has been translated into numerous languages, including Arabic for this study.
It comprises ten questions, with one evaluating the impact of the knee on daily activities and nine focusing on performance.
Scores range from 0 to 100, with higher scores indicating better health status (24).
|
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
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The Knee injury and Osteoarthritis Outcomes Score (KOOS)
Tidsramme: Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
|
The Knee Injury and Osteoarthritis Outcomes Score (KOOS) is a patient-reported outcome measure designed to assess the impact of knee injury or osteoarthritis on an individual's quality of life (25,26).
It includes subscales for pain, symptoms, activities of daily living (ADL), quality of life, and recreational activities (25,26).
Studies have shown that KOOS has superior psychometric characteristics compared to other measures.
It has been translated into 40 languages, including an Arabic version for use in Saudi Arabia, which will be utilized in our study (27,28).
KOOS comprises 42 items across five subscales: nine for pain, seven for symptoms, seventeen for ADL, five for sports and recreation function, and four for knee-related quality of life.
Each item is scored from 0 to 4, with higher scores indicating better health status (29).
|
Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
- (1) Englund M, Roos EM, Roos HP, Lohmander LS. Patient-relevant outcomes fourteen years after meniscectomy: influence of type of meniscal tear and size of resection. Rheumatology. 2001 Jun;40(6):631-9.
- (2) Wolf BR, Gulbrandsen TR. Degenerative Meniscus Tear in Older Athletes. Clin Sports Med. 2020 Jan;39(1):197-209.
- (3) Carlier PG, Bertoldi D, Baligand C, Wary C, Fromes Y. Muscle blood flow and oxygenation measured by NMR imaging and spectroscopy. NMR Biomed. 2006 Nov;19(7):954-67.
- (4) Gatehouse PD, Bydder GM. Magnetic Resonance Imaging of Short T2 Components in Tissue. Clin Radiol. 2003 Jan;58(1):1-19.
- (5) Gatehouse PD, Thomas RW, Robson MD, Hamilton G, Herlihy AH, Bydder GM. Magnetic resonance imaging of the knee with ultrashort TE pulse sequences. Magn Reson Imaging. 2004 Oct;22(8):1061-7.
- (6) Qian Y, Boada FE. Acquisition-weighted stack of spirals for fast high-resolution three-dimensional ultra-short echo time MR imaging. Magn Reson Med. 2008 Jul;60(1):135-45.
- (7) NOYES, F.R., S.D. BARBER, AND R.E. MANGINE. Abnormal lower limb symmetry determined by functional hop tests after anterior cruciate ligament rupture. Am. J. Sports Med. 19:513-518. 1991.
- (8) Ross MD, Langford B, Whelan PJ. Test-retest reliability of 4 single-leg horizontal hop tests. J Strength Cond Res. 2002 Nov;16(4):617-22.
- (9) BOLGLA, L.A., AND D.R. KESKULA. Reliability of lower extremity functional performance tests. J. Orthop. Sports Phys. Ther. 26:138- 142. 1997.
- (10) BOOHER, L.D., K.M. HENCH, T.W. WORRELL, AND J. STIKELEATHER. Reliability of three single-leg hop tests. J. Sport Rehab. 2:165- 170. 1993.
- (11) Ugalde V, Brockman C, Bailowitz Z, Pollard CD, Single Limb Squat Test and its Relationship to Dynamic Knee Valgus and Injury Risk Screening, PM&R (2014), doi: 10.1016/ j.pmrj.2014.08.361.
- (12) Ageberg E, Bennell KL, Hunt MA, Simic M, Roos EM, Creaby MW. Validity and inter-rater reliability of medio-lateral knee motion observed during a single-limb mini squat. BMC Musculoskelet Disord. 2010 Nov 16;11:265. doi: 10.1186/1471-2474-11-265.
- (13) Roos EM, Bremander AB, Englund M, Lohmander LS. Change in self-reported outcomes and objective physical function over 7 years in middle-aged subjects with or at high risk of knee osteoarthritis. Ann Rheum Dis. 2008 Apr;67(4):505-10. doi: 10.1136/
- (14) Bremander AB, Dahl LL, Roos EM. Validity and reliability of functional performance tests in meniscectomized patients with or without knee osteoarthritis. Scand J Med Sci Sports. 2007 Apr;17(2):120-7. doi: 10.1111/j.1600-0838.2006.00544.x. PMID: 1
- (15) Roos EM, Ostenberg A, Roos H, Ekdahl C, Lohmander LS. Long-term outcome of meniscectomy: symptoms, function, and performance tests in patients with or without radiographic osteoarthritis compared to matched controls. Osteoarthritis Cartilage 2001
- (16) Stensrud S, Risberg MA, Roos EM. Knee function and knee muscle strength in middle-aged patients with degenerative meniscal tears eligible for arthroscopic partial meniscectomy. Br J Sports Med. 2014 May;48(9):784-8. doi: 10.1136/bjsports-2012-091
- (17) Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
- (18) Rainville J, Jouve C, Finno M, Limke J. Comparison of four tests of quadriceps strength in l3 or l4 radiculopathies. Spine. 2003;28(21):2466-2471.
- (19) Suri P, Rainville J, Katz JN, et al. The accuracy of the physical examination for the diagnosis of midlumbar and low lumbar nerve root impingement. Spine. 2011;36(1):63-73.
- (20) Waldhelm A, Gubler C, Sullivan K, Witte C, Buchheister D, Bartz-Broussard J. INTER-RATER AND TEST-RETEST RELIABILITY OF TWO NEW SINGLE LEG SIT-TO-STAND TESTS. Int J Sports Phys Ther. 2020 May;15(3):388-94.
- (21) Fitzgerald GK, Piva SR, Irrgang JJ. A modified neuromuscular electrical stimulation protocol for quadriceps strength training following anterior cruciate ligament reconstruction. J Orthop Sports Phys Ther. 2003 Sep;33(9):492-501.
- (22) Bruce RA. Methods of exercise testing. Step test, bicycle, treadmill, isometrics. Am J Cardiol. 1974 May 20;33(6):715-20.
- (23) McInnis KJ, Balady GJ. Comparison of submaximal exercise responses using the Bruce vs modified Bruce protocols. Med Sci Sports Exerc. 1994 Jan;26(1):103-7.
- (24) Almalki H, Herrington L, Jones R. Arabic version of the International Knee Documentation Committee Subjective Knee Form (IKDC): Translation and validation. J Back Musculoskelet Rehabil. 2022;35(3):659-65.
- (25) Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD (1998) Knee Injury and Osteoarthritis Outcome Score (KOOS)- development of a self-administered outcome measure. J Orthop Sports Phys Ther 28:88-96.
- (26) Roos EM, Lohmander LS (2003) The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 1:64-68.
- (27) Garratt AM, Brealey S, Gillespie WJ (2004) Patient-assessed health instruments for the knee: a structured review. Rheumatology 43:1414-1423.
- (28) Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB (2009) Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions. Osteoarthr Cartil 17:1434-1439.
- (29) Alfadhel SA, Vennu V, Alnahdi AH, Omar MT, Alasmari SH, AlJafri Z, et al. Cross-cultural adaptation and validation of the Saudi Arabic version of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Rheumatol Int. 2018 Aug 7;38(8):1547-55.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Muskuloskeletale sygdomme
- Gigt
- Ledsygdomme
- Reumatiske sygdomme
- Slidgigt
- Slidgigt, knæ
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Træningsterapi
- Modstandstræning
Andre undersøgelses-id-numre
- 20230630
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