The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
8. november 2017 opdateret af: Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life.
The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program.
However, it is still unclear regarding the optimal exercise prescription after TKA.
In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment.
The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively.
Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined.
Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups.
Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients.
The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness.
This project will establish the scientific basis for rehabilitation protocol involving knee surgery.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
110
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Chiayi City, Taiwan, 613
- Sports Medicine Center, Chang Gung Memorial Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år til 85 år (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Exclusion Criteria:
- The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control
TKA patients without exercise intervention
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Eksperimentel: Exercise
TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise )
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cyclic exercise, aerobic exercise and resistant training exercise
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline bone mineral density
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA).
Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline lower extremity muscle strength
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min.
The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Motion analysis
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
|
Change from baseline SF-36 questionnaire assessment
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower score the more disability.
The higher the score the less disability.
Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health.
Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Change from baseline KOOS questionnaire assessment
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life.
Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms).
The User's Guide, is available from www.koos.nu.
The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
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Physical fitness---6-minutes' walk test
Tidsramme: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
|
The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month , six month and nine month after operation; twelve-month follow-up
|
|
Physical fitness---2.44 m up and go
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
The 2.44 m up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Physical fitness---30-sec sit to stand
Tidsramme: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
|
30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair.
Also reduces the chance of falling.
Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
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pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2013
Primær færdiggørelse (Faktiske)
31. oktober 2017
Studieafslutning (Faktiske)
31. oktober 2017
Datoer for studieregistrering
Først indsendt
18. september 2016
Først indsendt, der opfyldte QC-kriterier
7. oktober 2016
Først opslået (Skøn)
10. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. november 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. november 2017
Sidst verificeret
1. november 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CORPG6C0021-23
Plan for individuelle deltagerdata (IPD)
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