Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)
2022년 9월 12일 업데이트: Washington University School of Medicine
Remediating Age Related Cognitive Decline: Mindfulness-Based Stress Reduction and Exercise
The purpose of this research is to examine the effects of four interventions on age-related cognitive decline in healthy older adults.
The investigators will examine the effects of Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based aerobic exercise, and their combination, compared to a discussion group.
연구 개요
상세 설명
MBSR teaches mindfulness, or the focusing of attention and awareness, through various meditation techniques. Mindfulness meditation practices appear to produce neurocircuitry changes that are the reverse of those seen in age-related cognitive decline. It is widely available, acceptable to older people, and carries minimal risk of side effects or adverse events. Exercise - specifically, intense, multi-component exercise - also appears to affect brain structure and function and improve cognitive performance.
The investigators will randomize 580 non-demented healthy adults aged 65 to 84 to one of four conditions: MBSR alone, exercise alone, MBSR + exercise, or a health education discussion group control condition.
The study will consist of a 6-month acute intervention phase with weekly visits followed by a 12-month maintenance phase with weekly or monthly visits and other prompts to maintain intervention behaviors.
Assessments include cognitive tests, biomarkers, neuroimaging assessments, functional assessments to examine real-world benefits of the interventions, and other behavioral assessments to characterize participants and pave the way for further exploratory analyses.
연구 유형
중재적
등록 (실제)
585
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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California
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San Diego, California, 미국, 92122
- University of California San Diego
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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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
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Community-living men and women age 65 to 84.
- Self-reported cognitive complaints that are a normal part of aging.
- No current meditation practice nor prior training in it.
- Sedentary.
Exclusion Criteria:
- Known diagnosis of dementia, mild cognitive impairment, other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease), psychotic disorder, or any unstable psychiatric condition.
- Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or would interfere with the assessments, such as taking medications for diabetes or ferromagnetic metal/bridgework that would interfere with MRI signal.
- IQ <70 as estimated by the Wechsler Test of Adult Reading
- Sensory impairment (language, hearing, or visual) that would prevent participation.
- Alcohol abuse within 6 months.
- Current illicit drug use.
- Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity.
- Medications that interfere with measurements, including cancer chemotherapy, glucocorticoids, and interferon.
- Inability to cooperate with protocol.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: MBSR
Mindfulness-Based Stress Reduction consists of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months.
Content includes instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life.
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다른 이름들:
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실험적: Exercise
The exercise protocol is optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty.It consists of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months.
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다른 이름들:
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실험적: MBSR + Exercise
This condition will receive both MBSR and exercise as described above. Participants in this condition will come in once weekly to receive MBSR and twice weekly to receive exercise classes, with at-home exercise the other two days as well as daily, at-home mindfulness practice. After the initial classes participants will also attend additional weekly or monthly sessions until completion of the study. Note that at each site a pilot group is undergoing MBSR + Exercise (not randomized, separate from the RCT). |
다른 이름들:
다른 이름들:
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활성 비교기: Health Education
Health Education is a group-based intervention that increases health-related knowledge and action.
Health Education improves chronic disease management.Health Education consists of ten weekly 2.5-hour classes, followed by monthly classes for approximately 15 months.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Memory Composite Score
기간: Month 0, Month 3, Month 6, and Month 18
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The memory composite variable consists of the list recall, paragraph recall, and picture sequence memory tasks.
For each memory variable, a z score is computed for each participant [(participant score - mean)/standard deviation].
Then the composite memory variable is created by averaging the z scores.
The higher the z-score, the better the outcome.
A Z-score of 0 represents the population mean.
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Month 0, Month 3, Month 6, and Month 18
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Cognitive Control Composite Score
기간: Month 0, Month 3, Month 6, Month 18
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The cognitive control composite variable uses the CVOE, SART, Color Word Interference, flanker, dimensional change card sort, and list-sorting tasks.
For each cognitive variable, a z score is computed for each participant [(participant score - mean)/standard deviation].
Then the composite cognitive control variable is created by averaging the z scores.
The higher the z-score, the better the outcome.
A Z-score of 0 represents the population mean.
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Month 0, Month 3, Month 6, Month 18
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Hippocampal Volume
기간: Month 0, Month 6, Month 18
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The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, Month 18
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DLPFC Surface Area
기간: Month 0, Month 6, Month 18
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The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, Month 18
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DLPFC Cortical Thickness
기간: Month 0, Month 6, and Month 18
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The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
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Month 0, Month 6, and Month 18
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OTDL (Observed Tasks of Daily Living).
기간: Month 0, Month 6, Month 18
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The Revised Observed Tasks of Daily Living (OTDL-R) is a performance-based test of everyday problem-solving.
Subjects completed tasks testing medication use (following medicine label directions, and completing a patient record form); telephone use (finding and dialing a number from the yellow pages); and financial management (making change with coins and bills, and balancing a checkbook).
The scores were summed with the total score having a range from 0 to 28.
The higher the score, the more likely the participant is able to complete everyday activities.
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Month 0, Month 6, Month 18
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Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
기간: Month 0, Month 3, Month 6, Month 18
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The Quality of Life in Neurological Disorders (NQoL) Cognitive Function Scale is an 18-item self-report measure that assesses the health-related quality of life of adults.
The total score ranges from 18 to 90 where a higher score represents a better outcome.
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Month 0, Month 3, Month 6, Month 18
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Eric J Lenze, MD, Washington University School of Medicine
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 (실제)
2015년 4월 1일
기본 완료 (실제)
2020년 6월 1일
연구 완료 (실제)
2021년 5월 1일
연구 등록 날짜
최초 제출
2016년 1월 12일
QC 기준을 충족하는 최초 제출
2016년 1월 22일
처음 게시됨 (추정)
2016년 1월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 9월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 9월 12일
마지막으로 확인됨
2022년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 201410093
- 1R01AG049369-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available for release upon request to qualified investigators.
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. .
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