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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

Status

Afsluttet

Betingelser

Intervention / Behandling

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

      • Pizi, Taiwan, 613
        • Sports Medicine Center, Chang Gung Memorial Hospital

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
Ingen indgriben: Control
without exercise intervention
Eksperimentel: Exercise
Subjects with circuit exercise, aerobic dance, or Tai Chi exercise intervention.
circuit exercise, aerobic dance and Tai Chi exercise

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
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline elbow muscle strength
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
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.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
High-density lipoprotein from blood sample
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
High-density lipoprotein are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Triglyceride from blood sample
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Triglyceride are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Fasting blood glucose from blood sample
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Fasting blood glucose are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Blood pressure
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Diastolic and systolic blood pressure are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Weight parameters of the subjects
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Weight (kg) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Height parameters of the subjects
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Height (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up
Waistline parameters of the subjects
Tidsramme: Pre-intervention, 3-month, 6-month, 9-month-follow-up
Waistline (cm) are measured at Pre-intervention, 3-month, 6-month, 9-month-follow-up.
Pre-intervention, 3-month, 6-month, 9-month-follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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