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Postpartum Exercise Intervention

2026年5月21日 更新者：Rita Deering、Carroll University

Influence of a Supervised Postpartum Exercise Program on Maternal Physical Activity Levels and Musculoskeletal Health

The postpartum period is associated with decreases in physical activity levels, muscular strength, muscular endurance, and pelvic floor muscle function, but little scientific evidence exists on how best to initiate and progress exercise in the postpartum period. This proposal aims to improve habitual physical activity levels, neuromuscular health (i.e., strength, fatigability, symptom burden) and overall wellbeing (i.e., decreased fear of movement, improved sleep quality, improved perception of quality of life) through participation in a weekly exercise program. This study will help to inform postpartum exercise recommendations and is novel as it allows participants to incorporate their children into the exercise routine, thus removing a primary barrier to physical activity/exercise.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Physical activity (PA)/exercise is crucial for maternal health and wellbeing but several barriers to PA/exercise participation exist in the postpartum period. Musculoskeletal impairments-such as weakness, increased fatigability, pelvic floor dysfunction (e.g., incontinence, pelvic organ prolapse, etc.), and pain-are common in the postpartum period. While these impairments provide strong rationale for participation in PA/exercise, they can also act as barriers to participation. Several psychosocial barriers also exist, including fear of movement and lack of childcare. Despite the importance of PA/exercise for health and wellness, and the documented musculoskeletal impairments that are associated with the postpartum period, assessment of neuromuscular function and education on resuming exercise is lacking in the standard postpartum care model in the United States. In addition, conflicting information can be found on social media and among clinical experts on when and how to best resume PA/exercise after childbirth. This proposal will evaluate the influence of an eight-week exercise intervention on neuromuscular function (i.e., lower extremity strength & endurance, pelvic floor muscle strength & endurance, self-reported pelvic floor dysfunction symptoms), habitual physical activity levels, and overall wellbeing (i.e., levels of kinesiophobia, sleep quality, self-reported quality of life) in postpartum females. In an effort to decrease barriers to exercise, childcare will be offered, and participants will have the opportunity to incorporate their child(ren) into exercise sessions if they so desire. This proposal will utilize a randomized control trial (RCT) design and objective measures of strength (i.e., load cells) along with standard clinical assessments of pelvic floor muscle function (i.e., internal vaginal assessment of strength and endurance, self-reported symptoms using validated questionnaires).

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Wisconsin
      • Waukesha、Wisconsin、美国、53186
        • 招聘中
        • Carroll University Center for Graduate Studies
        • 接触：
        • 接触：
        • 首席研究员：
          • Rita E Deering, DPT, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 18 years of age or older
  • gave birth in the 24 months prior to study enrollment

Exclusion Criteria:

  • less than 6 weeks postpartum or not medically appropriate to engage in exercise regardless of time since childbirth (will be screened using the Get Active Questionnaire for Postpartum)
  • prescription anti-inflammatory/pain medications that are taken daily;
  • significant orthopedic conditions that would contraindicate performance of the fatigue task and participation in the exercise intervention (such as fractures, severe scoliosis, etc)
  • moderate to severe cardiovascular &/or pulmonary disease that contraindicates participation in exercise
  • neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc);
  • smoking/vaping or use of other tobacco or nicotine products (chewing tobacco, nicotine patches, nicotine gum, etc.)
  • use of any illegal drugs

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Exercise Intervention
Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.
诊断测试：主动直腿抬高试验
ASLR 测试是一项成熟的临床测试，可评估腰椎/骨盆的稳定性、骨盆后部疼痛的严重程度以及激活腹部肌肉的能力。 它是仰卧进行的。 参与者被指示抬起一条腿，膝盖伸直，脚跟高度为 20 厘米。 腿在顶部保持 5 秒钟，然后慢慢降低到地面。 要求参与者以 0 到 5 的等级（0 = 一点都不困难；5 = 无法抬起腿）和 0 到 10 的等级报告疼痛（0 = 没有疼痛；10 = 最差）可能的疼痛）。 如果困难或疼痛被评为 1 或更高，则重复测试，研究人员提供骨盆的外部压缩。 如果感觉到的困难或报告的疼痛随着压缩而降低，则该测试被认为是腰骨盆不稳的阳性结果。 然后在相反的肢体上重复测试。
其他名称：
  • ASLR测试
其他：主动直腿抬高疲劳任务
该协议类似于 ASLR 测试，不同之处在于参与者被指示尽可能长时间保持抬高的腿离开地面。 将在参与者的腰骨盆区域下方放置一个生物反馈气囊，以评估脊柱/骨盆的运动。 袖带将充气至 40 毫米汞柱，并指示参与者在整个测试过程中将针头保持在尽可能接近 40 毫米汞柱的水平；不会提供有关如何影响袖带压力的信息，但会在整个任务过程中提供袖带压力的视觉反馈。 将每 30-60 秒从参与者那里获得一次感知用力 (RPE) 和疼痛的评级。 任务失败将定义为鞋跟高度 ≤ 10 cm 或袖带压力变化 ≥ 20 mm Hg。 双肢都将接受测试，但会在不同的时段进行。 肢体测试的顺序（主导与非主导）将是随机的和平衡的。 肢体优势将自我报告。
诊断测试：腹壁超声成像
实时超声将用于评估脐上方和下方的直肠间距离。 参与者将在仰卧休息时、仰卧时抬头时以及仰卧时直腿抬高时使用 B 模式图像进行评估。 首席研究员接受过肌肉骨骼超声方面的培训和经验。
其他：Progressive exercise
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
其他名称：
  • 锻炼
其他：Lower Extremity Strength Testing
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity an MVC of the hip extensors of the grounded limb will be performed in supine before and within 2 minutes of completing the ASLR fatigue task. The straight leg raise MVC will be performed with a custom-made load cell instrumented strength testing device, which consists of a rigid platform on which the participant will lie. At the foot of the device is a tower that houses 2 load cells connected to a lightly padded push plate. The hip extension MVC will be performed on a force plate. Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed for each muscle group, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per muscle group will be performed following the ASLR Fatigue Task.
其他：Pelvic Floor Muscle Strength Testing
An internal vaginal pelvic floor muscle assessment will be performed at baseline and study completion by a licensed physical therapist with advanced training in pelvic floor muscle examination and treatment. Pelvic floor muscle function will be assessed using the PERFECT scale, which assesses both muscular strength ("P" for "power") and endurance ("E"). Strength is assessed by cueing the participant to perform a maximal voluntary pelvic floor muscle contraction while the examiner has their index finger inserted into the vagina. The modified Oxford scale is used to grade strength on a scale of zero (0) to five (5).
其他：Pelvic Floor Muscle Endurance Testing
Pelvic floor muscle endurance is also assessed via the internal vaginal PFM examination. After strength testing is performed, participants are instructed to perform a maximal PFM contraction and hold for as long as possible (maximum of 10 seconds). The examiner counts the length of the contraction, and timing is stopped either when (1) strength of the contraction declines or (2) the maximum of 10 seconds is reached. The time in seconds is recorded.
有源比较器：Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
诊断测试：主动直腿抬高试验
ASLR 测试是一项成熟的临床测试，可评估腰椎/骨盆的稳定性、骨盆后部疼痛的严重程度以及激活腹部肌肉的能力。 它是仰卧进行的。 参与者被指示抬起一条腿，膝盖伸直，脚跟高度为 20 厘米。 腿在顶部保持 5 秒钟，然后慢慢降低到地面。 要求参与者以 0 到 5 的等级（0 = 一点都不困难；5 = 无法抬起腿）和 0 到 10 的等级报告疼痛（0 = 没有疼痛；10 = 最差）可能的疼痛）。 如果困难或疼痛被评为 1 或更高，则重复测试，研究人员提供骨盆的外部压缩。 如果感觉到的困难或报告的疼痛随着压缩而降低，则该测试被认为是腰骨盆不稳的阳性结果。 然后在相反的肢体上重复测试。
其他名称：
  • ASLR测试
其他：主动直腿抬高疲劳任务
该协议类似于 ASLR 测试，不同之处在于参与者被指示尽可能长时间保持抬高的腿离开地面。 将在参与者的腰骨盆区域下方放置一个生物反馈气囊，以评估脊柱/骨盆的运动。 袖带将充气至 40 毫米汞柱，并指示参与者在整个测试过程中将针头保持在尽可能接近 40 毫米汞柱的水平；不会提供有关如何影响袖带压力的信息，但会在整个任务过程中提供袖带压力的视觉反馈。 将每 30-60 秒从参与者那里获得一次感知用力 (RPE) 和疼痛的评级。 任务失败将定义为鞋跟高度 ≤ 10 cm 或袖带压力变化 ≥ 20 mm Hg。 双肢都将接受测试，但会在不同的时段进行。 肢体测试的顺序（主导与非主导）将是随机的和平衡的。 肢体优势将自我报告。
诊断测试：腹壁超声成像
实时超声将用于评估脐上方和下方的直肠间距离。 参与者将在仰卧休息时、仰卧时抬头时以及仰卧时直腿抬高时使用 B 模式图像进行评估。 首席研究员接受过肌肉骨骼超声方面的培训和经验。
其他：Lower Extremity Strength Testing
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity an MVC of the hip extensors of the grounded limb will be performed in supine before and within 2 minutes of completing the ASLR fatigue task. The straight leg raise MVC will be performed with a custom-made load cell instrumented strength testing device, which consists of a rigid platform on which the participant will lie. At the foot of the device is a tower that houses 2 load cells connected to a lightly padded push plate. The hip extension MVC will be performed on a force plate. Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed for each muscle group, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per muscle group will be performed following the ASLR Fatigue Task.
其他：Pelvic Floor Muscle Strength Testing
An internal vaginal pelvic floor muscle assessment will be performed at baseline and study completion by a licensed physical therapist with advanced training in pelvic floor muscle examination and treatment. Pelvic floor muscle function will be assessed using the PERFECT scale, which assesses both muscular strength ("P" for "power") and endurance ("E"). Strength is assessed by cueing the participant to perform a maximal voluntary pelvic floor muscle contraction while the examiner has their index finger inserted into the vagina. The modified Oxford scale is used to grade strength on a scale of zero (0) to five (5).
其他：Pelvic Floor Muscle Endurance Testing
Pelvic floor muscle endurance is also assessed via the internal vaginal PFM examination. After strength testing is performed, participants are instructed to perform a maximal PFM contraction and hold for as long as possible (maximum of 10 seconds). The examiner counts the length of the contraction, and timing is stopped either when (1) strength of the contraction declines or (2) the maximum of 10 seconds is reached. The time in seconds is recorded.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Average Total Activity Counts (TAC) per day over 7 days
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring the TAC per day. TAC is the total number of filtered, full-wave rectified, integrated accelerations (all directions). These will then be averaged/day based on the total number of valid wear days for each participant.
7 days pre-intervention, 7 days post-intervention
Physical Activity Measured by Average Steps per day over 7 days
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean steps per day. This will be quantified as reported by the Ametris (formerly ActiGraph) accelerometer and CentrePoint analysis software. The Algorithm used by Ametris is not publicly available, but Ametris/ActiGraph accelerometers are frequently used in research quantifying physical activity.
7 days pre-intervention, 7 days post-intervention
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA. Intensity of physical activity assessed using tri-axial counts (per the accelerometer software) are as follows: Light physical activity is between 200 and 2690 counts/min, moderate intensity between 2690-6166 counts/min, and vigorous intensity is ≥ 6167 counts/min. MVPA is ≥2690.
7 days pre-intervention, 7 days post-intervention
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA. Intensity of physical activity assessed using vertical counts (per the accelerometer software) are as follows: Light physical activity is between 100 and 759 counts/min, moderate intensity is 760-5999 counts/min, and vigorous intensity is ≥ 6000 counts/min (MVPA is > 760 counts/min).
7 days pre-intervention, 7 days post-intervention
Average Minutes per Day of Activity in at least 5-minute bouts
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of all activity. Average minutes per day of activity within each of the following categories: light = 25.8 mg - 100.5 mg; moderate = 100.6 mg - 428.7 mg; vigorous = > 428.8 mg (mg is the vector magnitude of acceleration calculated in gravities using Euclidean Norm minus 1 metric)
7 days pre-intervention, 7 days post-intervention
Average Minutes per Day of Activity in at least 10-minute bouts
大体时间：7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of all activity. Average minutes per day of activity within each of the following categories: light = 25.8 mg - 100.5 mg; moderate = 100.6 mg - 428.7 mg; vigorous = > 428.8 mg. (mg is the vector magnitude of acceleration calculated in gravities using Euclidean Norm minus 1 metric)
7 days pre-intervention, 7 days post-intervention
Physical activity levels via self-reported questionnaires
大体时间：Once-a-week for the 8-week intervention period
Participants will complete the International Physical Activity Questionnaire (IPAQ) short-form. The IPAQ short-form quantifies physical activity (PA) over the previous week in 2 categories: low, moderate, or high activity; or metabolic equivalents (MET) minutes per week. High PA is categorized as (1)vigorous PA on at least 3 days/week with a combined minimum of at least 1500 MET minutes/week or (2) 7 days of cumulative PA of any intensity that sums to a minimum total of at least 3000 MET minutes/week. Moderate PA is categorized as (1) 3+ days of at least 30 minutes of vigorous PA, (2) 5+ days of moderate PA or walking at least 30 minutes/day, or (3) 5+ days of any level of PA that sums to a minimum of 600 MET minutes/week. Low physical activity is categorized as activity that does not meet the criteria for medium or high activity.
Once-a-week for the 8-week intervention period
Lower extremity strength
大体时间：Baseline and 7-14 days post-intervention
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity will be performed in supine before and within 2 minutes of completing the ASLR fatigue task with a custom made load cell instrumented strength testing device. This device consists of a rigid platform on which the study participant will lie supine. At the foot of the device is a tower that houses 2 load cells and is connected to a lightly padded push plate. This push plate can be raised and lowered such that the participant can push up into the plate (contacts the anterior surface of the participant's shin) or push down onto the push plate (contacts the posterior aspect of the participant's heel). Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed on each leg, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per leg will be performed following the fatigue task.
Baseline and 7-14 days post-intervention
Mean Time to ASLR Fatigue Task Failure
大体时间：Baseline and 7-14 days post-intervention
The Active Straight Leg Raise Fatigue Task will be administered. Participants are asked to raise one leg to a heel height of 20 cm while lying supine. Participants are encouraged to keep the leg raised as long as possible. Task failure will be defined as a heel height less than or equal to 10 centimeters off the ground.
Baseline and 7-14 days post-intervention
Pelvic floor muscle strength
大体时间：Baseline and 7-14 days post-intervention
An internal vaginal pelvic floor muscle assessment will be performed at baseline and study completion by a licensed physical therapist with advanced training in pelvic floor muscle examination and treatment. Pelvic floor muscle function will be assessed using the PERFECT scale, which assesses both muscular strength ("P" for "power") and endurance ("E"). Strength is assessed by cueing the participant to perform a maximal voluntary pelvic floor muscle contraction while the examiner has their index finger inserted into the vagina. The modified Oxford scale is used to grade strength on a scale of zero (0) to five (5) with 5 being the strongest.
Baseline and 7-14 days post-intervention
Pelvic floor muscle endurance
大体时间：Baseline and 7-14 days post-intervention
Pelvic floor muscle endurance is also assessed via the internal vaginal PFM examination. After strength testing is performed, participants are instructed to perform a maximal PFM contraction and hold for as long as possible (maximum of 10 seconds). The examiner counts the length of the contraction, and timing is stopped either when (1) strength of the contraction declines or (2) the maximum of 10 seconds is reached.55 The time in seconds is recorded.
Baseline and 7-14 days post-intervention
Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
大体时间：Baseline and 7-14 days post-intervention
The PFDI-20 is composed of 20 items total on three scales (Pelvic Organ Prolapse, Colorectal-Anal Distress, Urinary Distress), each scored on a 5 point likert scale. Mean scores from each scale are calculated and multiplied by 25, then added together for a total possible range of scores from 0-300. Higher scores indicate increased pelvic floor distress.
Baseline and 7-14 days post-intervention
Fear of movement
大体时间：Baseline and 7-14 days post-intervention
Fear of movement (kinesiophobia) will be assessed via the Tampa Scale for Kinesiophobia (TSK). The TSK is a 17-question, self-administered questionnaire that utilizes a 4-point Likert scale (1= strongly agree, 4=strongly disagree). Total scores range from 17-68. A higher score indicates higher levels of kinesiophobia; a score of 17 indicates no/minimal kinesiophobia.
Baseline and 7-14 days post-intervention
Overall quality of life
大体时间：Baseline and 7-14 days post-intervention
Participants will complete the SF-20 questionnaire, which measures health in six different domains (physical functioning, role functioning, social functioning, mental health, health perceptions, and pain). Scores range from 0-100%, with 0% being the worst score and 100% being the best.
Baseline and 7-14 days post-intervention
Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
大体时间：Baseline and 7-14 days post-intervention
The PSQI assesses seven sleep domains: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The seven components scores are then added to yield a global PSQI score in the range of zero to 21. Higher scores indicate worse sleep quality. A global score greater than five is diagnostic of poor sleep quality.
Baseline and 7-14 days post-intervention
Inter-recti distance
大体时间：Baseline and 7-14 days post-intervention
Ultrasound imaging will be used to measure the distance between the right and left rectus abdominis at 2 locations above the umbilicus and 2 locations below the umbilicus. IRD will be assessed in supine at rest (end exhalation), while lifting the head, and while lifting one leg.
Baseline and 7-14 days post-intervention

次要结果测量

结果测量
措施说明
大体时间
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
大体时间：Baseline and 7-14 days post-intervention
For the ASLR Fatigue Task, the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff placed under the participant's lumbopelvic region assesses movement of the spine/pelvis during the test. The cuff will be inflated to 40 mm Hg, and the participant will be instructed to keep the needle as close to 40 mm Hg as possible throughout the test. Pain Scores will be measured (0-10 with higher scores increased pan) every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg.
Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Abdominal Muscles
大体时间：Baseline and 7-14 days post-intervention
Electromyography (EMG) will be reported as the root mean square (RMS) value. The percent change in EMG from the start of the ASLR Fatigue task to task failure will be examined.
Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Rectus femoris
大体时间：Baseline and 7-14 days post-intervention
EMG for the rectus femoris will be normalized to the maximum RMS EMG obtained during lower extremity strength testing. The percent change in EMG from the start of the task to task failure will be examined.
Baseline and 7-14 days post-intervention

其他结果措施

结果测量
措施说明
大体时间
Root mean square (RMS) of global EMG
大体时间：Baseline and 7-14 days post-intervention
Muscle behavior will be quantified from surface EMG recordings of the rectus abdominis and rectus femoris using multi-channel array surface EMG electrodes during maximal and submaximal contractions and fatiguing exercise of the abdominal muscles. If successful, RMS of global EMG will be reported.
Baseline and 7-14 days post-intervention
Percent of Maximum Voluntary Isometric Contraction (MVIC)
大体时间：Baseline and 7-14 days post-intervention
Muscle activity will be quantified from surface EMG recordings of the rectus abdominis and rectus femoris using a multi-channel array surface EMG electrodes during submaximal contractions and fatiguing exercise of the abdominal muscles, and normalized to the RMS EMG during maximal voluntary isometric contractions (MVIC). If successful, percent of MVIC will be reported.
Baseline and 7-14 days post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Carroll University

调查人员

  • 首席研究员：Rita Deering, DPT, PhD、Carroll University
  • 研究主任：Kimberly Klug, DSc、Carroll University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月19日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2025年11月20日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月21日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-061

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Data will be archived in the NICHD Data and Specimen Hub (DASH). Per the DASH protocol, study data will be assigned a digital object identifier (DOI). Data will also be able to be found via searching for keywords (e.g., postpartum exercise).

IPD 共享时间框架

Data will be made available following completion of data collection. Data will be shared for as long as possible per DASH guidelines.

IPD 共享访问标准

Data will be accessible to any person with access to DASH. Access to scientific data will not be controlled by study personnel. All 18 identifiers listed in the HIPAA Privacy Rule will be removed from data shared in the DASH repository to protect study participants.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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