- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02936336
The Effect of Exercise Intervention on the Community's Older Adults
11. mai 2018 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
411
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pizi, Taiwan, 613
- Sports Medicine Center, Chang Gung Memorial Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control
without exercise intervention
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
|
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
|
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
|
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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Robert Wen-Wei HSU, MD, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2009
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
13. oktober 2016
Først innsendt som oppfylte QC-kriteriene
14. oktober 2016
Først lagt ut (Anslag)
18. oktober 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2018
Sist bekreftet
1. mai 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CMRPG690111-3;CMRPG6A0421-22
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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