Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders (SCIBHI)
27 september 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
120
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Shanghai, China
- Huashan hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar tot 79 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Actieve vergelijker: 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-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in cognitive performance on battery of neuropsychological tests
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in whole brain volume
Tijdsspanne: Baseline, 8 months
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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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: James A Mortimer, Ph.D., University of South Florida
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2008
Primaire voltooiing (Werkelijk)
1 september 2009
Studie voltooiing (Werkelijk)
1 september 2009
Studieregistratiedata
Eerst ingediend
26 september 2012
Eerst ingediend dat voldeed aan de QC-criteria
27 september 2012
Eerst geplaatst (Schatting)
28 september 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
28 september 2012
Laatste update ingediend die voldeed aan QC-criteria
27 september 2012
Laatst geverifieerd
1 september 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Byrd-ARG2007
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