Mindfulness-Based Stress Reduction, Health Education and Exercise (MEDEX)
2022年9月12日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
585
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
California
-
San Diego、California、アメリカ、92122
- University Of California San Diego
-
-
Missouri
-
Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年～84年 (高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
他の名前：
|
|
実験的：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.
|
他の名前：
|
|
実験的：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). |
他の名前：
他の名前：
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Memory Composite Score
時間枠：Month 0, Month 3, Month 6, and Month 18
|
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.
|
Month 0, Month 3, Month 6, and Month 18
|
|
Cognitive Control Composite Score
時間枠：Month 0, Month 3, Month 6, Month 18
|
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.
|
Month 0, Month 3, Month 6, Month 18
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hippocampal Volume
時間枠：Month 0, Month 6, Month 18
|
The hippocampal volume is derived from structural MRI high-resolution T1-weighted images.
|
Month 0, Month 6, Month 18
|
|
DLPFC Surface Area
時間枠：Month 0, Month 6, Month 18
|
The Dorsal Lateral Pre-Frontal Cortex (DLPFC) surface area is derived from structural MRI high-resolution T1-weighted images.
|
Month 0, Month 6, Month 18
|
|
DLPFC Cortical Thickness
時間枠：Month 0, Month 6, and Month 18
|
The Dorsal Lateral Pre-Frontal Cortex Cortical Thickness is derived from structural MRI high-resolution T1-weighted images.
|
Month 0, Month 6, and Month 18
|
|
OTDL (Observed Tasks of Daily Living).
時間枠：Month 0, Month 6, Month 18
|
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.
|
Month 0, Month 6, Month 18
|
|
Quality of Life in Neurological Disorders Cognitive Function Scale (NQoL).
時間枠：Month 0, Month 3, Month 6, Month 18
|
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.
|
Month 0, Month 3, Month 6, Month 18
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Eric J Lenze, MD、Washington University School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年4月1日
一次修了 (実際)
2020年6月1日
研究の完了 (実際)
2021年5月1日
試験登録日
最初に提出
2016年1月12日
QC基準を満たした最初の提出物
2016年1月22日
最初の投稿 (見積もり)
2016年1月27日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月28日
QC基準を満たした最後の更新が送信されました
2022年9月12日
最終確認日
2022年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 201410093
- 1R01AG049369-01 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
健康教育の臨床試験
-
University of North Texas Health Science CenterNational Institute on Minority Health and Health Disparities (NIMHD)完了
-
Tulane UniversityUniversity of Alabama at Birmingham; Louisiana State University Health Sciences Center in New... と他の協力者終了しました
-
Cumhuriyet University募集
-
Nordsjaellands HospitalLund University; Region Capital Denmark; Ostfold University College; University College Copenhagen; Sahlgrenska University Hospital募集
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない