A New Translational Tool for Studying the Role of Breathing in Meditation
2020年11月20日 更新者：University of California, San Francisco
Project Inspire: A New Translational Tool for Studying the Role of Breathing in Meditation
A recent National Health Interview Survey reported that breathing exercises were the second most common complementary and alternative medicine practice in the United States, following only the use of "natural products."
With such widespread interest in breathing exercises, alone or as a component of practices such as meditation, a need exists for research that examines not only its efficacy, but also investigates potential mechanisms of action.
Indeed, a recent National Center for Complementary and Alternative Medicine (NCCAM) Meditation Workshop recommended research to clarify biological pathways by which meditation practices, including breathing exercises, can impact health.
To explore mechanisms underlying the health effects of breathing exercises, new translational tools are needed that can measure breathing patterns in both the clinic and natural environment.
The primary objective of the present proposal is the application of a new technology to the investigation of pathways by which breathing exercises can affect health.
For this project, the health-related outcome measure to be studied is a major cardiovascular risk factor, blood pressure.
調査の概要
研究の種類
介入
入学 (実際)
99
段階
- 適用できない
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
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria
- Mean 24-hr SBP: 130-139 mmHg
- Female
- > 50 years of age
- Post menopausal, defined as greater than or equal to one year without a menstrual cycle.
- Body Mass Index (BMI): 19-31
- English speaking (Patients not able to read and speak English will be excluded as the behavioral group interventions are conducted in English)
- Has a personal physician
Exclusion Criteria (Individuals will be filtered in the KP OSCA database according to the following ICD-9 codes):
Respiration:
- 491.X chronic Bronchitis incl COPD
- 492.X emphysema
- 493.X asthma
- 494-496; 500-519: all kinds of chronic pulmonary conditions
Cardiovascular:
- 404.9 chronic ischemic heart disease
- 425.X cardiomyopathies
- 428.X heart failure
- 430-438 cerebrovascular diseases
Kidney:
- 582-583 chronic glomerulonephritis
- 584-588 renal failure
Liver:
- 571.X chronic liver disease and cirrhosis Smoker: 305.1
Psychiatric:
- 290-299 dementia/schizophrenia/ psychoses…
- 303, 304 alcohol or drug dependence
- 317-319 mental retardation
Medications:
- All blood pressure medications
- All tranquilizers, benzodiazepins if prescribed regularly, e.g. every month
- All narcotics if prescribed regularly, e.g. every month
Other:
- Plan to relocate residence outside recruitment area during the intervention or follow- period
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Mindful Breathing (MB)
The MB intervention is based off of the Mindfulness Based Stress Reduction Program developed by Jon Kabat-Zinn.
Participants will be organized into cohorts of eight, and attend eight weekly MB sessions.
Mindful breathing consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, perceptions and events, from a non-evaluative, non-judgmental perspective.
No other intervention is included.
No FDA drug or device is involved.
|
The Mindful Breathing (MB)intervention is based on MBSR developed by Jon Kabat-Zinn.
Participants will attend 8 individual weekly MB sessions.
MB consists of closely "following the breath," throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, from a non-evaluative or judgmental perspective.
As attention wanders to concerns or thoughts, participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing.
Participants in MB will have their breathing rate and PetCO2 monitored during the 8 training sessions with a breathing monitor.
|
|
他の：Usual Care (UC)
Usual Care consists of the standard care made available to participants through their primary physician.
No intervention is included.
No FDA drug or device is involved.
|
This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and (Blood Pressure) BP, and completion of questionnaires.
Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition.
UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online "Healthy Lifestyle Programs".
We will assess the extent to which participants in both MB and UC used these resources.
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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 |
|---|---|---|
|
Blood Pressure
時間枠：Up to Week 25
|
Measured using Ambulatory, 24-Hr BP monitor
|
Up to Week 25
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Clinic (resting) blood pressure
時間枠：Up to Week 25
|
Up to Week 25
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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。
捜査官
- 主任研究者：Margaret A Chesney, PhD、University of California, San Francisco
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)
2011年2月1日
一次修了 (実際)
2017年7月31日
研究の完了 (実際)
2017年8月31日
試験登録日
最初に提出
2010年12月15日
QC基準を満たした最初の提出物
2010年12月21日
最初の投稿 (見積もり)
2010年12月22日
学習記録の更新
投稿された最後の更新 (実際)
2020年11月24日
QC基準を満たした最後の更新が送信されました
2020年11月20日
最終確認日
2020年11月1日
詳しくは
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。