Randomized Trial of Exercise and Social Interaction in a Community-Based Sample of Non-Demented Chinese Elders (SCIBHI)
2012년 9월 27일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
120
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Shanghai, 중국
- Huashan Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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활성 비교기: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in cognitive performance on battery of neuropsychological tests
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in whole brain volume
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: James A Mortimer, Ph.D., University of South Florida
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 7월 1일
기본 완료 (실제)
2009년 9월 1일
연구 완료 (실제)
2009년 9월 1일
연구 등록 날짜
최초 제출
2012년 9월 26일
QC 기준을 충족하는 최초 제출
2012년 9월 27일
처음 게시됨 (추정)
2012년 9월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 9월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 9월 27일
마지막으로 확인됨
2012년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Fast walking에 대한 임상 시험
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Seattle Children's Hospital모병아동 행동 문제 | 아동 파괴적 행동 장애 | 동료 지원 | 도전적인 행동 | 부모 자식 관계 | 긍정적인 육아 | 학부모 관리 교육미국
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Aurora Health CareAurora BayCare Medical Center; BayCare Health System완전한
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Septodont완전한
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University of British ColumbiaHeart and Stroke Foundation of Canada알려지지 않은
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James F. Holmes, MD, MPHEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Pediatric Emergency Care Applied Research Network모병
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University of California, San DiegoNational Institute of Mental Health (NIMH)완전한
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Smith & Nephew, Inc.모집하지 않고 적극적으로