The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
8. November 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
110
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Chiayi City, Taiwan, 613
- Sports Medicine Center, Chang Gung Memorial Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre bis 85 Jahre (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Control
TKA patients without exercise intervention
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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from baseline bone mineral density
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from baseline lower extremity muscle strength
Zeitfenster: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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
Zeitfenster: 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
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Change from baseline SF-36 questionnaire assessment
Zeitfenster: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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
Zeitfenster: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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
Zeitfenster: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
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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
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Physical fitness---2.44 m up and go
Zeitfenster: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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
Zeitfenster: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
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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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2013
Primärer Abschluss (Tatsächlich)
31. Oktober 2017
Studienabschluss (Tatsächlich)
31. Oktober 2017
Studienanmeldedaten
Zuerst eingereicht
18. September 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Oktober 2016
Zuerst gepostet (Schätzen)
10. Oktober 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. November 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. November 2017
Zuletzt verifiziert
1. November 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CORPG6C0021-23
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UNENTSCHIEDEN
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