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Postpartum Exercise Intervention

21 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Wisconsin
      • Waukesha, Wisconsin, Stati Uniti, 53186
        • Reclutamento
        • Carroll University Center for Graduate Studies
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Rita E Deering, DPT, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Exercise Intervention
Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.
Il test ASLR è un test clinico consolidato che valuta la stabilità della colonna lombare/bacino, la gravità del dolore pelvico posteriore e la capacità di attivare i muscoli addominali. Si esegue in posizione supina. Ai partecipanti viene chiesto di sollevare una gamba, con il ginocchio dritto, a un'altezza del tallone di 20 cm. La gamba viene tenuta in alto per 5 secondi, quindi abbassata lentamente a terra. Al partecipante viene chiesto di riportare la difficoltà percepita a sollevare la gamba su una scala da 0 a 5 (0=per niente difficile; 5=impossibilità di sollevare la gamba) e il dolore su una scala da 0 a 10 (0=nessun dolore; 10=peggiore possibile dolore). Se la difficoltà o il dolore sono valutati a 1 o superiore, il test viene ripetuto con il ricercatore che fornisce compressione esterna del bacino. Se la difficoltà percepita o il dolore riferito sono inferiori con la compressione, il test è considerato positivo per l'instabilità lombopelvica. Il test viene quindi ripetuto sull'arto opposto.
Altri nomi:
  • Prova ASLR
Il protocollo è simile al test ASLR, tranne per il fatto che al partecipante viene chiesto di mantenere la gamba sollevata da terra il più a lungo possibile. Un bracciale ad aria per biofeedback verrà posizionato sotto la regione lombopelvica del partecipante per valutare il movimento della colonna vertebrale/bacino. Il bracciale verrà gonfiato a 40 mm Hg e il partecipante verrà incaricato di mantenere l'ago il più vicino possibile a 40 mm Hg durante il test; non verranno fornite informazioni su come influenzare la pressione del bracciale, ma durante l'attività verrà fornito un feedback visivo della pressione del bracciale. Le valutazioni dello sforzo percepito (RPE) e del dolore saranno ottenute dai partecipanti ogni 30-60 secondi. Il fallimento del compito sarà definito come un'altezza del tallone ≤10 cm o un cambiamento nella pressione del bracciale ≥20 mm Hg. Verranno testati entrambi gli arti, ma in sessioni diverse. L'ordine dei test sugli arti (dominante vs non dominante) sarà randomizzato e controbilanciato. La dominanza degli arti sarà auto-riportata.
Verranno utilizzati ultrasuoni in tempo reale per valutare la distanza inter-retta sopra e sotto l'ombelico. I partecipanti saranno valutati con immagini in modalità B in posizione supina a riposo, in posizione supina mentre si solleva la testa e in posizione supina durante l'esecuzione di un sollevamento della gamba tesa. Il Principal Investigator ha formazione ed esperienza nell'ecografia muscoloscheletrica.
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
Altri nomi:
  • Esercizio
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.
Comparatore attivo: Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
Il test ASLR è un test clinico consolidato che valuta la stabilità della colonna lombare/bacino, la gravità del dolore pelvico posteriore e la capacità di attivare i muscoli addominali. Si esegue in posizione supina. Ai partecipanti viene chiesto di sollevare una gamba, con il ginocchio dritto, a un'altezza del tallone di 20 cm. La gamba viene tenuta in alto per 5 secondi, quindi abbassata lentamente a terra. Al partecipante viene chiesto di riportare la difficoltà percepita a sollevare la gamba su una scala da 0 a 5 (0=per niente difficile; 5=impossibilità di sollevare la gamba) e il dolore su una scala da 0 a 10 (0=nessun dolore; 10=peggiore possibile dolore). Se la difficoltà o il dolore sono valutati a 1 o superiore, il test viene ripetuto con il ricercatore che fornisce compressione esterna del bacino. Se la difficoltà percepita o il dolore riferito sono inferiori con la compressione, il test è considerato positivo per l'instabilità lombopelvica. Il test viene quindi ripetuto sull'arto opposto.
Altri nomi:
  • Prova ASLR
Il protocollo è simile al test ASLR, tranne per il fatto che al partecipante viene chiesto di mantenere la gamba sollevata da terra il più a lungo possibile. Un bracciale ad aria per biofeedback verrà posizionato sotto la regione lombopelvica del partecipante per valutare il movimento della colonna vertebrale/bacino. Il bracciale verrà gonfiato a 40 mm Hg e il partecipante verrà incaricato di mantenere l'ago il più vicino possibile a 40 mm Hg durante il test; non verranno fornite informazioni su come influenzare la pressione del bracciale, ma durante l'attività verrà fornito un feedback visivo della pressione del bracciale. Le valutazioni dello sforzo percepito (RPE) e del dolore saranno ottenute dai partecipanti ogni 30-60 secondi. Il fallimento del compito sarà definito come un'altezza del tallone ≤10 cm o un cambiamento nella pressione del bracciale ≥20 mm Hg. Verranno testati entrambi gli arti, ma in sessioni diverse. L'ordine dei test sugli arti (dominante vs non dominante) sarà randomizzato e controbilanciato. La dominanza degli arti sarà auto-riportata.
Verranno utilizzati ultrasuoni in tempo reale per valutare la distanza inter-retta sopra e sotto l'ombelico. I partecipanti saranno valutati con immagini in modalità B in posizione supina a riposo, in posizione supina mentre si solleva la testa e in posizione supina durante l'esecuzione di un sollevamento della gamba tesa. Il Principal Investigator ha formazione ed esperienza nell'ecografia muscoloscheletrica.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Average Total Activity Counts (TAC) per day over 7 days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Root mean square (RMS) of global EMG
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Rita Deering, DPT, PhD, Carroll University
  • Direttore dello studio: Kimberly Klug, DSc, Carroll University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 febbraio 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 agosto 2028

Date di iscrizione allo studio

Primo inviato

20 novembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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).

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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