- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02936336
The Effect of Exercise Intervention on the Community's Older Adults
11. maj 2018 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
411
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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Pizi, 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
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Control
without exercise intervention
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline bone mineral density
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change from baseline elbow muscle strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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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
1. november 2009
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
13. oktober 2016
Først indsendt, der opfyldte QC-kriterier
14. oktober 2016
Først opslået (Skøn)
18. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2018
Sidst verificeret
1. maj 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CMRPG690111-3;CMRPG6A0421-22
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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