- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02936336
The Effect of Exercise Intervention on the Community's Older Adults
11. Mai 2018 aktualisiert von: Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
The Effect of Exercise Intervention on the Physical Fitness, Bone Mineral Density and Health-related Quality of Life in the Community's Older Adults
Osteoporosis is a serious global health problem, second only to cardiovascular disease.
Osteoporosis is the most common metabolic bone disease in the elderly population, characterized by loss of bone mineral density (BMD) and continuous destruction of bone microstructure, especially in postmenopausal women.
It gives rise to bone fragility and fracture risk.
Moreover, as people grow older, falls frequently occur with high severity, and nearly 35% to 45% of persons aged 65 or older fall at least once a year.
Osteoporotic fractures increase mortality, morbidity, chronic pain, and the cost of social care and it decreases the quality of life.
Here, investigators plan to perform different exercise interventions such as circuit exercise, aerobic dance and Tai Chi on the community's older adults to evaluate whether exercise intervention could improve the bone mineral density, physical fitness, muscle strength or quality of life.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
411
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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Pizi, 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
45 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Being >45 years-of-age,
- Healthy and physically independent.
Exclusion Criteria:
- The exclusion criteria were individuals on hormone replacement therapy and those with cognitive impairment, progressive debilitating conditions, bone fractures, or any medical contraindications to administering the fitness assessment.
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: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Control
without exercise intervention
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Experimental: Exercise
Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.
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circuit exercise, aerobic dance and Tai Chi 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-intervention, 3-month, 6-month, 9-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-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change from baseline elbow muscle strength
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of elbow 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 Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline shoulder muscle strength
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of shoulder 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 Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline hip muscle strength
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of hip 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 Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline knee muscle strength
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Extension and flexion of knee 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 Muscle strength was present as a peak torque which was normalized to body weight (Unit:Nm/kg).
The participants are assessed at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Change from baseline SF-36 questionnaire assessment
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-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-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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High-density lipoprotein from blood sample
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Triglyceride from blood sample
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Fasting blood glucose from blood sample
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Blood pressure
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Weight parameters of the subjects
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Height parameters of the subjects
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Waistline parameters of the subjects
Zeitfenster: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
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Pre-intervention, 3-month, 6-month, 9-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
1. November 2009
Primärer Abschluss (Tatsächlich)
1. Dezember 2013
Studienabschluss (Tatsächlich)
1. Dezember 2013
Studienanmeldedaten
Zuerst eingereicht
13. Oktober 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Oktober 2016
Zuerst gepostet (Schätzen)
18. Oktober 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Mai 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Mai 2018
Zuletzt verifiziert
1. Mai 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CMRPG690111-3;CMRPG6A0421-22
Plan für individuelle Teilnehmerdaten (IPD)
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UNENTSCHIEDEN
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