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.
調査の概要
状態
募集
詳細な説明
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).
研究の種類
介入
入学 (推定)
50
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：Rita Deering, DPT, PhD
- 電話番号：2629513047
- メール：deeringresearch@carrollu.edu
研究場所
-
-
Wisconsin
-
Waukesha、Wisconsin、アメリカ、53186
- 募集
- Carroll University Center for Graduate Studies
-
コンタクト：
- Rita E Deering, DPT, PhD
- 電話番号：2629513047
- メール：rdeering@carrollu.edu
-
コンタクト：
- Kimberly Klug, PT, DSc
- メール：kklug@carrollu.edu
-
主任研究者：
- Rita E Deering, DPT, PhD
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
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：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Exercise Intervention
Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.
|
ASLR テストは、腰椎/骨盤の安定性、骨盤後部の痛みの重症度、腹筋を活性化する能力を評価する、十分に確立された臨床テストです。
仰臥位で行われます。
参加者は、膝をまっすぐにして片足をかかとの高さ 20 cm まで上げるように指示されます。
脚を5秒間保持し、ゆっくりと地面に下ろします。
参加者は、脚を上げることの困難さを 0 ～ 5 のスケール (0= 全く困難ではない、5= 脚を上げることができない) と痛みを 0 ～ 10 のスケール (0= 痛みなし、10= 最悪) で報告するように求められます。痛みの可能性があります）。
困難または痛みが 1 以上と評価された場合、研究者が骨盤の外部圧迫を加えてテストが繰り返されます。
知覚される困難または報告された痛みが圧迫により軽減される場合、このテストは腰骨盤不安定性について陽性であるとみなされる。
次に、反対側の肢でもテストを繰り返します。
他の名前：
このプロトコルは、参加者ができるだけ長く地面から上げた脚を維持するように指示されることを除いて、ASLR テストに似ています。
脊椎/骨盤の動きを評価するために、バイオフィードバック エア カフを参加者の腰骨盤領域の下に配置します。
カフは 40 mm Hg まで膨張し、参加者はテスト中ずっと針をできるだけ 40 mm Hg に近づけるよう指示されました。カフ圧にどのように影響するかについての情報は提供されませんが、タスク全体を通じてカフ圧の視覚的なフィードバックが提供されます。
知覚労作（RPE）と痛みの評価は、参加者から 30 ～ 60 秒ごとに取得されます。
課題の失敗は、かかとの高さ ≤ 10 cm、またはカフ圧の変化 ≥ 20 mm Hg として定義されます。
両方の手足がテストされますが、異なるセッションで行われます。
四肢テストの順序 (ドミナントと非ドミナント) はランダム化され、バランスがとられます。
四肢の優位性は自己申告されます。
リアルタイムの超音波を使用して、臍の上下の直腸間の距離を評価します。
参加者は、安静時の仰臥位、頭を上げている間の仰臥位、および脚をまっすぐ上げている間の仰臥位の B モード画像で評価されます。
主任研究者は筋骨格系超音波検査の訓練を受け、経験を積んでいます。
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
他の名前：
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.
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).
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.
|
|
アクティブコンパレータ：Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
|
ASLR テストは、腰椎/骨盤の安定性、骨盤後部の痛みの重症度、腹筋を活性化する能力を評価する、十分に確立された臨床テストです。
仰臥位で行われます。
参加者は、膝をまっすぐにして片足をかかとの高さ 20 cm まで上げるように指示されます。
脚を5秒間保持し、ゆっくりと地面に下ろします。
参加者は、脚を上げることの困難さを 0 ～ 5 のスケール (0= 全く困難ではない、5= 脚を上げることができない) と痛みを 0 ～ 10 のスケール (0= 痛みなし、10= 最悪) で報告するように求められます。痛みの可能性があります）。
困難または痛みが 1 以上と評価された場合、研究者が骨盤の外部圧迫を加えてテストが繰り返されます。
知覚される困難または報告された痛みが圧迫により軽減される場合、このテストは腰骨盤不安定性について陽性であるとみなされる。
次に、反対側の肢でもテストを繰り返します。
他の名前：
このプロトコルは、参加者ができるだけ長く地面から上げた脚を維持するように指示されることを除いて、ASLR テストに似ています。
脊椎/骨盤の動きを評価するために、バイオフィードバック エア カフを参加者の腰骨盤領域の下に配置します。
カフは 40 mm Hg まで膨張し、参加者はテスト中ずっと針をできるだけ 40 mm Hg に近づけるよう指示されました。カフ圧にどのように影響するかについての情報は提供されませんが、タスク全体を通じてカフ圧の視覚的なフィードバックが提供されます。
知覚労作（RPE）と痛みの評価は、参加者から 30 ～ 60 秒ごとに取得されます。
課題の失敗は、かかとの高さ ≤ 10 cm、またはカフ圧の変化 ≥ 20 mm Hg として定義されます。
両方の手足がテストされますが、異なるセッションで行われます。
四肢テストの順序 (ドミナントと非ドミナント) はランダム化され、バランスがとられます。
四肢の優位性は自己申告されます。
リアルタイムの超音波を使用して、臍の上下の直腸間の距離を評価します。
参加者は、安静時の仰臥位、頭を上げている間の仰臥位、および脚をまっすぐ上げている間の仰臥位の B モード画像で評価されます。
主任研究者は筋骨格系超音波検査の訓練を受け、経験を積んでいます。
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.
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).
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.
|
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 |
|---|---|---|
|
Average Total Activity Counts (TAC) per day over 7 days
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Root mean square (RMS) of global EMG
時間枠：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)
時間枠：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
|
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：Rita Deering, DPT, PhD、Carroll University
- スタディディレクター：Kimberly Klug, DSc、Carroll 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2月19日
一次修了 (推定)
2028年5月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2025年11月20日
QC基準を満たした最初の提出物
2026年5月21日
最初の投稿 (実際)
2026年5月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月29日
QC基準を満たした最後の更新が送信されました
2026年5月21日
最終確認日
2026年4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
- 2025-061
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
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 共有時間枠
Data will be made available following completion of data collection.
Data will be shared for as long as possible per DASH guidelines.
IPD 共有アクセス基準
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.
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。