Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders (SCIBHI)
27. september 2012 oppdatert av: University of South Florida
A Pilot Randomized Intervention Study of Physical Exercise and Social Engagement in Chinese Elders
A pilot randomized clinical trial was conducted in a random sample of 120 non-demented Chinese elders (ages 60-79) living in a defined community in Shanghai, China to compare the effects of interventions (fast walking, Tai Chi, group intellectual discussion) to no intervention with respect to change in cognition and whole brain volume determined by repeated neuropsychological batteries and MRI scans.
Aims included determining the feasibility of recruiting and retaining a random sample of people age 60+ for such a trial as well as collection of preliminary data on the efficacy of the interventions.
The long-term goal of this research program is to determine whether sustained physical and/or mental exercise interventions are efficacious in delaying the onset of dementia and to understand the role and mechanisms of brain growth in this process.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
Physical exercise has been shown to increase brain volume and improve cognition in randomized trials of non-demented elderly.
Although greater social engagement was found to reduce dementia risk in observational studies, randomized trials of social interventions have not been reported.
A representative sample of 120 elderly from Shanghai, China was randomized to four groups (Tai Chi, Walking, Social Interaction, No Intervention) for 40 weeks.
Two MRI's were obtained, one before the intervention period, the other after.
A neuropsychological battery was administered at baseline, 20 weeks and 40 weeks.
Comparison of changes in brain volumes in intervention groups with the No Intervention group were assessed by t-tests.
Time-intervention group interactions for neuropsychological measures were evaluated with repeated-measures mixed models.
Studietype
Intervensjonell
Registrering (Faktiske)
120
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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Shanghai, Kina
- Huashan 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
60 år til 79 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- living in defined area
- either sex
- aged 60-79
Exclusion Criteria:
- history of stroke, Parkinson's disease or other neurologic disease
- inability to walk unassisted for two kilometers or maintain balance with feet side-by-side or semi-tandem for 10 seconds each
- education-adjusted Chinese Mini-Mental Examination score < 26 (to exclude individuals with dementia or moderate cognitive impairment
- cardiovascular or musculoskeletal conditions that would be contraindicated for the intervention programs
- contraindications for MRI
- diagnosis of any illness that would preclude participation in the full study
- regular vigorous exercise or Tai Chi practice.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Fast walking
Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route.
Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises.
Prior to the first session, each participant was given a pedometer with their name on it.
They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement.
At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded.
A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
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Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route.
Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises.
Prior to the first session, each participant was given a pedometer with their name on it.
They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement.
At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded.
A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
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Aktiv komparator: Tai Chi
Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions.
Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
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Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions.
Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
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Aktiv komparator: Intellectual stimulation
Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center.
Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
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Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center.
Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
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Placebo komparator: Contact and testing only
The fourth group received no intervention.
Contact was maintained by phone during the intervention period to reduce dropout.
Participants were called four times during the 40 weeks intervention period by the study coordinator.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in cognitive performance on battery of neuropsychological tests
Tidsramme: Baseline, 4 months, 8 months
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A comprehensive battery of neuropsychological tests was administered by a psychometrist.
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Baseline, 4 months, 8 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in whole brain volume
Tidsramme: Baseline, 8 months
|
Structural MRIs were obtained at baseline and 8 months to provide data from which change in whole brain volume was determined.
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Baseline, 8 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: James A Mortimer, Ph.D., University of South Florida
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. juli 2008
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
26. september 2012
Først innsendt som oppfylte QC-kriteriene
27. september 2012
Først lagt ut (Anslag)
28. september 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. september 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. september 2012
Sist bekreftet
1. september 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Byrd-ARG2007
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