Inspiring Seniors Towards Exercise Promotion - 2 (iSTEP-2)
2026年7月22日 更新者：Kyoung Shin Park, PhD、Emory University
Older adults' low adherence to the national physical activity guidelines may stem from a failure to increase positive affective responses to exercise (e.g., enjoyment).
Exercising with personalized, tempo-synchronous music playlists has shown promising effects on physical activity promotion in midlife-to-older adults during a cardiac rehab program.
The purpose of this study is to determine how personalized, tempo-synchronous music playlists called rhythmic auditory stimulation (RAS) influence exercise behavior change and affective responses to exercise over 8 months among community-dwelling, sedentary older adults.
調査の概要
状態
募集
条件
詳細な説明
Participants 65 years and older will be offered an exercise program for six months, either with or without RAS.
The exercise program is based on the national physical activity guidelines for older adults and designed to train participants to independently engage in strength training and moderate-intensity aerobic training through the gradual withdrawal of supervised exercise classes (2 days/week for 3 months and 1 day/week for an additional 3 months).
At baseline, every month during the 6-month intervention, and 2-month post-intervention follow-up, we assess weekly volume of physical activity (primary outcome) using a hip-worn activity tracker and affective attitude toward physical activity (mechanistic outcome) through text-message-based ecological momentary assessment (EMA).
Before and after the 6-month intervention, participants will complete a lab visit for the assessment of cognitive, vascular, and physical functioning, fitness, anthropometry, and quality of life.
研究の種類
介入
入学 (推定)
150
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。
研究連絡先
- 名前：Kaetlin Marsh, MPH
- 電話番号：404-544-2381
- メール：kaetlin.marsh@emory.edu
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30329
- 募集
- Emory University
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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
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Adults over 65 years old.
- Ambulatory without pain or the use of assisted walking devices.
- Able to speak and read English.
- Healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician.
- Living in the community for the duration of the study (9-10 months).
- Having a reliable means of transportation.
- Having a safe place at home or at a residential area (at least 6 feet by 6 feet of open space) for unsupervised exercise training.
- Being low-active (< 90 min/week of MAT and < 2 days/week of ST for the last 3 months).
Exclusion Criteria:
- Diagnosed progressive, neurodegenerative, or severe central nervous system disorders (e.g., Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, or history of stroke with residual deficits) that significantly impair cognitive function, motor skills, or the ability to engage in independent exercise training over moderate intensity
- Participants with a history of episodic or peripheral neurological conditions (such as neuralgia or migraines) or stable cardiovascular/metabolic conditions may be included if they receive formal written medical clearance from their primary care physician or treating specialist, confirming it is safe for them to engage in unsupervised exercise training at moderate intensity.
- Known exercise contraindications (uncontrolled hypertension, joint problems, diabetes, metabolic conditions, etc.), determined by self-report on the PAR-Q+.
- Current or upcoming cancer treatment, determined by self-report on the PAR-Q+.
- Stroke or neural impairment in the past 6 months, as self-reported on the PAR-Q+.
- Hip/knee/spinal fracture or surgery in the past 6 months, determined by self-report on the ACSM Health Screening Questionnaire.
- Unable or unwilling to attend intervention classes, as determined by phone screening.
- Currently participating in any other exercise or fitness-related research study, determined by phone screening.
- Use of medications for cognitive impairment, as self-reported on the medication survey.
- Initiation or change in dosage of psychiatric medications (e.g., antidepressants, anxiolytics) within the past 8 weeks; participants must be on a stable dose for at least 2 months before enrollment and intend to maintain this dose throughout the 8-month study period.
- Self-report regularly drinking > 14 alcoholic beverages a week or current illicit drug use, determined by self-report to screening surveys.
- Current regular or hazardous use of illicit substances, or misuse of prescription medications, that occurs on a weekly or more frequent basis, or any substance use that, in the judgment of the investigator, would systematically confound weekly affective assessments or compromise safety during unsupervised exercise training, determined by self-report to screening surveys
- Cannot ambulate without a walker/cane, assessed in the American College of Sports Medicine (ACSM) Health Screening Questionnaire
- Having cognitive impairment, determined by the Montreal Cognitive Assessment (MoCA) BLIND < 17.
- Meet the threshold for clinical depression, determined by the Center for Epidemiological Studies Depression Scale Revised (CESD-R).
- Uncorrected hearing or visual impairments, self-reported on the Health History Questionnaire.
- Unable to understand the study procedure.
- One of the household members is participating in this study, as self-reported during phone screening.
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 |
|---|---|
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実験的：Exercise intervention with RAS (EX+RAS)
Participants will be randomized to an exercise intervention with RAS (EX+RAS) over 6 months, offering the exercise prescription to foster independent adherence to the Physical Activity guidelines (PAG) through the gradual withdrawal of supervised training.
This group will be provided with RAS playlists and trained to use them for their exercise sessions.
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Supervised exercise sessions will be led by an exercise specialist at an open-floor gym.
All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week.
Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week.
Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.
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アクティブコンパレータ：Exercise intervention without RAS (EX)
Participants will be randomized to an exercise intervention (EX) over 6 months, offering the same exercise prescription as the experimental group, to foster independent adherence to the PAG through the gradual withdrawal of supervised training.
This group will not be provided with any RAS playlists to accompany their exercise.
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Supervised exercise sessions will be led by an exercise specialist at an open-floor gym.
All participants will be asked to attend a supervised group exercise session for moderate aerobic training (MAT) for 15-40 minutes/day and muscle-strengthening training (ST) for 15-20 minutes/day for 2 days/week for the first 3 months, while being encouraged to independently perform MAT on up to 3 more days/week.
Then, the same training session will be offered for 1 day/week for an additional 3 months while encouraging participants to independently perform ST on 1 more day of the week and MAT up to 4 more days of the week.
Participants will be instructed on set and track exercise goals, supplemented with a series of behavioral supports during the 6-month intervention and until a 2-month post-intervention follow-up.
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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 |
|---|---|---|
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Weekly volume of light, moderate, and vigorous physical activity as assessed by ActiGraph
時間枠：7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention)
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Duration, intensity, and frequency of physical activity will be assessed using a waist-worn accelerometer.
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7 consecutive days at Baseline (before the intervention) and during month 1, 2, 3, 4, 5, and 6 (during intervention) and month 8 (2 months post-intervention)
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Daily duration of aerobic and strenght training as recorded on an Exercise Log
時間枠：During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)
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Self-reported daily duration and types of physical activity will be self-reported on an exercise log.
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During month 1, 2, 3, 4, 5, 6, 7 (during the intervention) and month 8 (2 months post - intervention until 2-month post-intervention)
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Affective response to exercise measured by the single-item Feeling Scale (FS)
時間枠：For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)
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The single-item Feeling Scale (FS) will be used to measure affective responses to physical activity as assessed by Ecological Momentary Assessment (EMA).
How are you feeling right now? with 11-point rating scale scores ranging from -5 to +5, with labels -5 = very bad, -3 = bad, -1 = somewhat bad, 0 = neutral, +1 = somewhat good, +3 = good, and +5 = very good.
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For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body Weight
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Measurements will be taken using the InBody380 scan.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Skeletal muscle mass
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Skeletal muscle mass will be measured using the InBody380 scan.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Body fat percentage
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Body fat percentage (percent body fat) will be measured using the InBody380 scan.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Sagittal abdominal diameter
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The progress of balance, sit-to-stand, and walking as assessed by Timed Up and Go test
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The time taken to complete a Timed Up and Go test is an indicator of fall risks.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Perceived exertion measured by the Borg's Rating of Perceived Exertion (RPE) scale
時間枠：For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)
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Borg's Rating of Perceived Exertion (RPE) scale will be used to assess perceived exertion during physical activity as assessed by Ecological Momentary Assessment (EMA).
Scores range from 6 to 20, with verbal anchors of 7 = very, very light, 9 = very light, 11 = fairly light, 13 = somewhat hard, 15 = hard, 17 = very hard, and 19 = very, very hard.
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For 3 days at Baseline (before the intervention), weekly during month 1, 2, 3, 4, 5, and 6 (during intervention), and for 3 days in month 8 (2 months post-intervention)
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Subjective cognitive decline measured by the Cognitive Change Index (CCI-12)
時間枠：At pre-test (before the intervention) and 6 weeks post-intervention
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The Cognitive Change Index (CCI-12) is a 12-item questionnaire assessing self or informant-perceived decline in episodic memory over the past 5 years.
It uses a 5-point Likert scale (1=no change, 5=much worse), with higher total scores (range 12-60) indicating greater perceived decline.
It acts as a marker for dementia risk, subjective cognitive decline (SCD), and early Alzheimer's.
The CCI-12 ranges from 12 to 60. Higher scores signify greater perceived decline.
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At pre-test (before the intervention) and 6 weeks post-intervention
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Exercise motivation measured by the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3)
時間枠：Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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The Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) is a 19 to 24-item tool (commonly 23-24 items) used to assess motivation for physical activity based on Self-Determination Theory.
It measures six types of motivation, ranging from not at all motivated to intrinsically motivated,.
Likert Scale Range: 0 to 4 (0 = "Not true for me", 4 = "Very true for me").
Higher average scores (closer to 4) indicate that a particular regulation style is a strong reason for exercising.
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Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Affective attitude toward physical activity measured by the Physical Activity Enjoyment Scale (PACES)
時間枠：Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Physical Activity Enjoyment Scale (PACES) to assess affective attitude toward PA.
Self-reported affective states relative to physical activity.
The Physical Activity Enjoyment Scale has 18 items on a 7-point Likert scale, and the total score ranges from 18 to 126.
A total score of 63 can be used to distinguish between enjoyment (>63) and lack of enjoyment (<63).
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Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Individual confidence in regular exercise measured by the Self-Efficacy for Exercise Scale (SEE)
時間枠：Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Self-Efficacy for Exercise Scale (SEE) is a self-report tool used to measure an individual's confidence in their ability to perform exercises regularly (e.g., 3 times per week for 20+ minutes) despite common barriers. The scale consists of 9 items. Scale: Each item is rated on an 11-point Likert scale ranging from 0 (Not Confident) to 10 (Very Confident). Minimum Score: 0 (representing zero confidence). Maximum Score: 90 (representing maximum confidence). Total Score Calculation: The total score is calculated by summing the responses to all 9 items. A higher total score indicates higher self-efficacy for exercise. 0-30: Low self-efficacy (low confidence in overcoming barriers to exercise). 31-60: Moderate self-efficacy. 61-90: High self-efficacy (high confidence in maintaining an exercise routine). |
Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Individual barriers in regular exercise measured by Barriers to Being Active survey (BBA)
時間枠：Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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The Barriers to Being Active (BBA) survey is a 21-item questionnaire developed by the Centers for Disease Control and Prevention (CDC) to identify personal obstacles to exercise.
It measures seven distinct categories of barriers, with each category containing 3 items.
Each of the 21 questions is rated on a 4-point Likert scale: Very likely (3 points), Somewhat likely (2 points), Somewhat unlikely (1 point), Very unlikely (0 points).
Since there are 3 questions per category, the minimum score is 0, and the maximum score is 9 per barrier.
The minimum total score is 0, and the maximum total score is 63 (21 items × 3 points).
Significant Barrier: A score of 5 or higher in any of the seven categories indicates that it is an important barrier to overcome.
Low Barrier: A score below 5 indicates the barrier is less significant.
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Baseline (pre-intervention), and during month 3 and 6 (during intervention) and month 8 (2 months post-intervention)
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Physical activity and sedentary behaviors measured by Physical and Sedentary Behaviour Questionnaire (PASB-Q)
時間枠：At pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The Physical and Sedentary Behaviour Questionnaire (PASB-Q) is a tool used to assess an adult's typical weekly physical activity, muscle strengthening, and sedentary habits.
It is not a single standardized 0-100 score, but rather a questionnaire that measures specific behaviors and can be used to gauge whether an individual meets physical activity guidelines.
The questionnaire measures several aspects of physical activity.
There is no set "maximum" score, as it measures frequency and duration, but the "minimum" is 0. It calculates the total minutes of moderate-to-vigorous aerobic physical activity per week.
Minutes/day = Total Minutes/Week.
Interpretation: Higher minutes per week indicate higher activity levels.
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At pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Health-related quality of life measured by RAND 36-item Health Survey (RAND-36)
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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RAND 36-item Health Survey (RAND-36) to assess health-related quality of life.
The RAND 36-Item Short-Form Health Survey Scale has 36 items for self-report, takes 10-15 minutes to complete, and measures health-related quality of life with a score ranging from 0 to 100, where 0 indicates the lowest possible health state (worst health), and 100 indicates the highest possible health state (best health).
Higher scores always represent better health status.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Sleep disturbance measured by the Pittsburgh Sleep Quality Index (PSQI)
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to evaluate sleep quality over a one-month interval.
It measures seven components of sleep, with a total global score ranging from 0 to 21. Minimum Score: 0 (Indicates no difficulty/excellent sleep quality).Maximum Score: 21 (Indicates severe difficulties in all areas/very poor sleep quality).
Higher Score = Worse Sleep: A higher total score indicates poorer sleep quality.
Scoring of 5: "Good" sleeper (low level of sleep disturbance) and > 5: "Poor" sleeper (indicates significant, relevant sleep disturbances)
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Depression measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) is a 20-item self-report questionnaire designed to measure the frequency and severity of depressive symptoms over the past two weeks.
It is used to identify individuals who may need a further clinical evaluation for depression.
Minimum Score (0): Indicates that the individual experienced almost no depressive symptoms, or that symptoms were present for less than one day, over the past two weeks.
Maximum Score (80): Indicates high frequency and severity, suggesting all 20 symptoms were present nearly every day for the past two weeks.
Total Score Range: The CESD-R uses a 5-point scale (0 to 4 per item), resulting in a total range of 0 to 80.
A total score of >=16 or >= 17 generally indicates a risk for clinical depression or significant depressive symptoms.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Perceived stress measured by the NIH Toolbox Perceived Stress Scale (PSS).
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The NIH Toolbox Perceived Stress Scale (PSS) is a 10-item self-report questionnaire designed to measure how unpredictable, uncontrollable, and overloaded a person finds their life to be over the past month. The PSS is part of the NIH Toolbox Emotion Battery. Minimum Score (0): Indicates no perceived stress. Maximum Score (40): Indicates very high perceived stress. Calculation: Responses are scored on a scale of 0 (Never) to 4 (Very Often). Four positive items are reversed (0=4, 1=3, 2=2, 3=1, 4=0) before summing all 10 items for a total score. 0-13 (Low Stress): Below-average stress, generally feel in control. 14-26 (Moderate Stress): Average stress level, manageable but may warrant attention. 27-40 (High Stress): Elevated, high stress, often associated with poorer health outcomes. |
Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Arterial fitness (carotid-femoral pulse wave velocity) as measured by the SphygmoCor XCEL system
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The SphygmoCor XCEL system provides measurements on pulse wave velocity, which will serve as the outcome of interest in arterial fitness.
It is measured in units of meters per second, at which blood pressure waves travel through the circulatory system.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Central aortic blood pressure (systolic and diastolic, mmHg) as measured by the SphygmoCor XCEL system
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Central aortic pressure measures blood pressure directly at the root of the aorta, and is measured in units of millimeters of mercury (mmHg).
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Music-related reward experiences measured by the Barcelona Music Reward Questionnaire (BMRQ) to assess music-related reward experiences
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The Barcelona Music Reward Questionnaire (BMRQ) assesses music-related reward experiences. It consists of 20 items rated from 1 (completely disagree) to 5 (completely agree), with scores ranging from 0 to 100. Musical Anhedonia (Low): <= 65. These individuals derive little to no pleasure from music despite having normal hearing and cognitive function. Average/Normal Reward: 66 - 86. The majority of the population falls within this middle range. Hyperhedonia (High): >= 87. These individuals experience unusually strong emotional or physical responses to music. |
Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Waist circumference
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Hip circumference
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Leg circumference
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Measurements will be taken using a standardized anthropometric protocol (abdominal caliper)
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The auditory stimulation score
時間枠：During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)
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Auditory stimulation score as assessed by a 10-item custom-developed Playlist Rating survey Developed by the research team, this 10-item survey assesses the extent to which audio and video playlists motivate individuals in strength and aerobic training.
Items are scored on a Likert-based scale (1=Strongly disagree, 7=Strongly agree).
Scores are stratified by method of playlist administration (i.e., audio and video) and then summed, where higher scores represent higher levels of auditory stimulation.
The total score ranges from 5 to 35 for aerobic and strength training, with higher scores indicating greater auditory stimulation.
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During month 3 and 6 (during intervention) and 8 months (2 months post-intervention)
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Gait speed at normal and brisk pace (meters/second) as assessed by the 10-Meter Walk Test (10MWT)
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The 10-meter walk test (10MWT) assesses gait speed by timing a patient walking a 6-meter distance, usually within a 10-meter path to allow for acceleration/deceleration. It is a standardized assessment for gait by measuring the time taken at the 2m and 8m markers during the timed, steady-state portion.
This outcome measure reports gait speed in meters per second (m/s) at normal and brisk pace.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Aerobic fitness as assessed by the total distance walked in 6-minute walk test
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The distance in meters covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Hand Grip Strength
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Hand Grip Strength as measured by a Jamar hand dynamometer.
The squeeze power in kilograms is measured by a handheld Jamar dynamometer.
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Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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The progress of balance as assessed by 4-Stage Balance Test
時間枠：Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Standing balance (time held, in seconds) as assessed by the 4-Stage Balance Test. The duration in seconds of maintaining 4 difference postures. |
Pre-test (before the intervention) and post-test within 6 weeks after the intervention
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Lower-body strength as assessed by 30-Second Sit-to-Stand test
時間枠：At pre-test (before the intervention) and post-test, within 6 weeks after the intervention
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The number of sit-to-stand maneuvers completed in 30 seconds.
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At pre-test (before the intervention) and post-test, within 6 weeks after the intervention
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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。
スポンサー
捜査官
- 主任研究者：Kyoung Shin Park, PhD、Emory University
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)
2026年5月26日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年5月14日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月23日
QC基準を満たした最後の更新が送信されました
2026年7月22日
最終確認日
2026年7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
- 2025P011936
- R33AG084479 (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
Researchers will share individual deidentified participant data that underlie the results reported from this trial (text, tables, figures, and appendices).
IPD 共有時間枠
Data will be shared beginning 9 months following the article publication and will be available for at least 10 years after the end of the funding period.
IPD 共有アクセス基準
Data will be shared with anyone who registers with the repository and agrees to its Terms of Use, which limit data use to scientific research and aggregate statistical reporting, prohibit attempts to re-identify study participants, and prohibit redistribution of downloaded data.
Data will be shared for any scientific research or aggregate statistical reporting consistent with the Terms of Use.
Data will be deposited in UNC Dataverse, which assigns a DOI as a persistent identifier and provides searchable study-level metadata for discovery. The dataset will be available for direct download through the repository interface upon registration and acceptance of the Terms of Use.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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。