- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01983930
Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment
연구 개요
상세 설명
The purpose of this pilot study intervention is to investigate brain mechanisms of response to memory enhancement training (MET) compared to Kundalini yoga and "Kirtan Kriya" meditation using functional magnetic resonance imaging (fMRI) that will be acquired from each subject at baseline and at 12 weeks (post-randomization).
Overall, the investigators anticipate recruiting 66 adults with memory complaints and diagnosed with MCI for adults 55 years old and older. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. All assessments will be completed immediately after the interventions for a total of 10 visits in 12 weeks and a follow-up visit at 6 months (24 weeks)to monitor the overall benefit of the intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095
- UCLA Semel Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Mild cognitive impairment amnestic type
- Clinical Dementia Rating scale score of 0.5
- SufficientEnglish proficiency and 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV
- Capacity to provide informed consent.
Exclusion criteria:
- Any current or past psychiatric disorders, or recent unstable medical or neurological disorders
- Any disabilities preventing their participation in the memory enhancement training (MET) (e.g. severe visual or hearing impairment)
- Insufficient English proficiency
- Diagnosis of dementia
- Mini Mental Health Examination score of 24 and below
- Psychoactive medications
- Participation in a psychotherapy that involves cognitive training
- Do not meet criteria for Mild cognitive impairment subtype
- Prior or current training in yoga.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 기억력 훈련
기억상실증 경도인지장애(MCI)에 대한 집단기억훈련 실시 예정
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참가자는 12주 동안 매주 기억력 훈련 수업에 참석하고 12주 동안 매일 기억력 숙제(12분 소요)를 받게 됩니다.
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실험적: Kundalini yoga and meditation
Participants will engage in weekly yoga classes and daily 20 minute meditation
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참가자는 12주 동안 매주 60분 요가 및 명상 세션에 참여하고 12주 동안 매일 Kirtan Kriya 명상(12분 지속)을 배정받게 됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score
기간: At baseline and at 6 months
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Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning.
Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores.
The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials.
When scoring the HVLT, the three learning trials are combined to calculate a total recall score.
Total scores range from 0-36 with higher scores indicating better outcome.
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At baseline and at 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical Global Impression Scale
기간: Baseline, weeks 2, 4, 6, 8, 10, 12, 24
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The CGI measures severity of illness and global improvement.
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).
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Baseline, weeks 2, 4, 6, 8, 10, 12, 24
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Geriatric Depression Scale (GDS)
기간: Baseline and Week 24
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Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials.
The GDS is a 30-item screening tool used to identify depression in older adults.
In scoring the Geriatric Depression Scale, each item is scored 0 or 1.
The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.
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Baseline and Week 24
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Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity
기간: Baseline and week 12
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FMRI scans will be obtained at baseline and after 12 weeks follow up.
Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.
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Baseline and week 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Helen Lavretsky, MD, MS, UCLA Semel Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13-000821
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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