Postpartum Exercise Intervention
21 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Statut
Recrutement
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
- Test diagnostique: Test actif d'élévation de la jambe droite
- Autre: Tâche active de fatigue pour lever la jambe droite
- Test diagnostique: Imagerie échographique de la paroi abdominale
- Autre: Progressive exercise
- Autre: Lower Extremity Strength Testing
- Autre: Pelvic Floor Muscle Strength Testing
- Autre: Pelvic Floor Muscle Endurance Testing
Description détaillée
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).
Type d'étude
Type d'étude
Interventionnel
Inscription (Estimé)
Inscription
50
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Rita Deering, DPT, PhD
- Numéro de téléphone: 2629513047
- E-mail: deeringresearch@carrollu.edu
Lieux d'étude
-
-
Wisconsin
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Waukesha, Wisconsin, États-Unis, 53186
- Recrutement
- Carroll University Center for Graduate Studies
-
Contact:
- Rita E Deering, DPT, PhD
- Numéro de téléphone: 2629513047
- E-mail: rdeering@carrollu.edu
-
Contact:
- Kimberly Klug, PT, DSc
- E-mail: kklug@carrollu.edu
-
Chercheur principal:
- Rita E Deering, DPT, PhD
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Nombre de bras
2
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
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Expérimental: Exercise Intervention
Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.
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Le test ASLR est un test clinique bien établi qui évalue la stabilité de la colonne lombaire/du bassin, la sévérité de la douleur pelvienne postérieure et la capacité à activer les muscles abdominaux.
Elle est réalisée en décubitus dorsal.
Les participants sont invités à lever une jambe, le genou droit, à une hauteur de talon de 20 cm.
La jambe est maintenue en haut pendant 5 secondes, puis lentement abaissée au sol.
Le participant est invité à signaler la difficulté perçue à lever la jambe sur une échelle de 0 à 5 (0=pas du tout difficile ; 5=incapable de lever la jambe) et la douleur sur une échelle de 0 à 10 (0=pas de douleur ; 10=pire douleurs éventuelles).
Si la difficulté ou la douleur sont évaluées à 1 ou plus, le test est répété avec le chercheur fournissant une compression externe du bassin.
Si la difficulté perçue ou la douleur signalée sont plus faibles avec la compression, le test est considéré comme positif pour l'instabilité lombo-pelvienne.
Le test est ensuite répété sur le membre opposé.
Autres noms:
Le protocole est similaire au test ASLR, sauf que le participant est chargé de maintenir la jambe surélevée au-dessus du sol aussi longtemps que possible.
Un brassard d'air de biofeedback sera placé sous la région lombo-pelvienne du participant pour évaluer le mouvement de la colonne vertébrale/du bassin.
Le brassard sera gonflé à 40 mm Hg et le participant devra garder l'aiguille aussi proche que possible de 40 mm Hg tout au long du test ; aucune information ne sera fournie sur la façon d'affecter la pression du brassard, mais un retour visuel de la pression du brassard sera fourni tout au long de la tâche.
Les évaluations de l'effort perçu (RPE) et de la douleur seront obtenues des participants toutes les 30 à 60 secondes.
L'échec de la tâche sera défini comme une hauteur de talon ≤ 10 cm ou un changement de pression du brassard ≥ 20 mm Hg.
Les deux membres seront testés, mais dans des sessions différentes.
L'ordre des tests des membres (dominant vs non dominant) sera randomisé et contrebalancé.
La dominance des membres sera autodéclarée.
L'échographie en temps réel sera utilisée pour évaluer la distance inter-recti au-dessus et au-dessous de l'ombilic.
Les participants seront évalués avec des images en mode B en décubitus dorsal au repos, en décubitus dorsal tout en levant la tête et en décubitus dorsal tout en effectuant une élévation de la jambe droite.
Le chercheur principal possède une formation et une expérience en échographie musculo-squelettique.
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
Autres noms:
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.
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Comparateur actif: Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
|
Le test ASLR est un test clinique bien établi qui évalue la stabilité de la colonne lombaire/du bassin, la sévérité de la douleur pelvienne postérieure et la capacité à activer les muscles abdominaux.
Elle est réalisée en décubitus dorsal.
Les participants sont invités à lever une jambe, le genou droit, à une hauteur de talon de 20 cm.
La jambe est maintenue en haut pendant 5 secondes, puis lentement abaissée au sol.
Le participant est invité à signaler la difficulté perçue à lever la jambe sur une échelle de 0 à 5 (0=pas du tout difficile ; 5=incapable de lever la jambe) et la douleur sur une échelle de 0 à 10 (0=pas de douleur ; 10=pire douleurs éventuelles).
Si la difficulté ou la douleur sont évaluées à 1 ou plus, le test est répété avec le chercheur fournissant une compression externe du bassin.
Si la difficulté perçue ou la douleur signalée sont plus faibles avec la compression, le test est considéré comme positif pour l'instabilité lombo-pelvienne.
Le test est ensuite répété sur le membre opposé.
Autres noms:
Le protocole est similaire au test ASLR, sauf que le participant est chargé de maintenir la jambe surélevée au-dessus du sol aussi longtemps que possible.
Un brassard d'air de biofeedback sera placé sous la région lombo-pelvienne du participant pour évaluer le mouvement de la colonne vertébrale/du bassin.
Le brassard sera gonflé à 40 mm Hg et le participant devra garder l'aiguille aussi proche que possible de 40 mm Hg tout au long du test ; aucune information ne sera fournie sur la façon d'affecter la pression du brassard, mais un retour visuel de la pression du brassard sera fourni tout au long de la tâche.
Les évaluations de l'effort perçu (RPE) et de la douleur seront obtenues des participants toutes les 30 à 60 secondes.
L'échec de la tâche sera défini comme une hauteur de talon ≤ 10 cm ou un changement de pression du brassard ≥ 20 mm Hg.
Les deux membres seront testés, mais dans des sessions différentes.
L'ordre des tests des membres (dominant vs non dominant) sera randomisé et contrebalancé.
La dominance des membres sera autodéclarée.
L'échographie en temps réel sera utilisée pour évaluer la distance inter-recti au-dessus et au-dessous de l'ombilic.
Les participants seront évalués avec des images en mode B en décubitus dorsal au repos, en décubitus dorsal tout en levant la tête et en décubitus dorsal tout en effectuant une élévation de la jambe droite.
Le chercheur principal possède une formation et une expérience en échographie musculo-squelettique.
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.
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Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Average Total Activity Counts (TAC) per day over 7 days
Délai: 7 days pre-intervention, 7 days post-intervention
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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.
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7 days pre-intervention, 7 days post-intervention
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Physical Activity Measured by Average Steps per day over 7 days
Délai: 7 days pre-intervention, 7 days post-intervention
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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.
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7 days pre-intervention, 7 days post-intervention
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Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
Délai: 7 days pre-intervention, 7 days post-intervention
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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.
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7 days pre-intervention, 7 days post-intervention
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Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
Délai: 7 days pre-intervention, 7 days post-intervention
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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).
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7 days pre-intervention, 7 days post-intervention
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Average Minutes per Day of Activity in at least 5-minute bouts
Délai: 7 days pre-intervention, 7 days post-intervention
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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)
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7 days pre-intervention, 7 days post-intervention
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Average Minutes per Day of Activity in at least 10-minute bouts
Délai: 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)
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7 days pre-intervention, 7 days post-intervention
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Physical activity levels via self-reported questionnaires
Délai: Once-a-week for the 8-week intervention period
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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.
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Once-a-week for the 8-week intervention period
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Lower extremity strength
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Mean Time to ASLR Fatigue Task Failure
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Pelvic floor muscle strength
Délai: Baseline and 7-14 days post-intervention
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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
|
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Pelvic floor muscle endurance
Délai: 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.
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Baseline and 7-14 days post-intervention
|
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Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Fear of movement
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Overall quality of life
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Inter-recti distance
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Percent Change in Global Surface EMG Recordings: Abdominal Muscles
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Percent Change in Global Surface EMG Recordings: Rectus femoris
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Autres mesures de résultats
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Root mean square (RMS) of global EMG
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Percent of Maximum Voluntary Isometric Contraction (MVIC)
Délai: Baseline and 7-14 days post-intervention
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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.
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Baseline and 7-14 days post-intervention
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Chercheur principal: Rita Deering, DPT, PhD, Carroll University
- Directeur d'études: Kimberly Klug, DSc, Carroll University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
19 février 2026
Achèvement primaire (Estimé)
Achèvement primaire
1 mai 2028
Achèvement de l'étude (Estimé)
Achèvement de l'étude
1 août 2028
Dates d'inscription aux études
Première soumission
Première soumission
20 novembre 2025
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
21 mai 2026
Première publication (Réel)
Première publication
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mai 2026
Dernière vérification
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 2025-061
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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).
Délai de partage IPD
Data will be made available following completion of data collection.
Data will be shared for as long as possible per DASH guidelines.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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