Postpartum Exercise Intervention
21. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
- Diagnostický test: Aktivní test zvedání rovné nohy
- Jiný: Aktivní únavový úkol zvedat rovnou nohu
- Diagnostický test: Ultrazvukové zobrazení břišní stěny
- Jiný: Progressive exercise
- Jiný: Lower Extremity Strength Testing
- Jiný: Pelvic Floor Muscle Strength Testing
- Jiný: Pelvic Floor Muscle Endurance Testing
Detailní popis
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).
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
50
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Rita Deering, DPT, PhD
- Telefonní číslo: 2629513047
- E-mail: deeringresearch@carrollu.edu
Studijní místa
-
-
Wisconsin
-
Waukesha, Wisconsin, Spojené státy, 53186
- Nábor
- Carroll University Center for Graduate Studies
-
Kontakt:
- Rita E Deering, DPT, PhD
- Telefonní číslo: 2629513047
- E-mail: rdeering@carrollu.edu
-
Kontakt:
- Kimberly Klug, PT, DSc
- E-mail: kklug@carrollu.edu
-
Vrchní vyšetřovatel:
- Rita E Deering, DPT, PhD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: Exercise Intervention
Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.
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ASLR test je dobře zavedený klinický test, který hodnotí stabilitu bederní páteře/pánve, závažnost zadní pánevní bolesti a schopnost aktivovat břišní svaly.
Provádí se vleže.
Účastníci jsou instruováni, aby zvedli jednu nohu s rovným kolenem do výšky paty 20 cm.
Noha je držena nahoře po dobu 5 sekund, poté pomalu spuštěna na zem.
Účastník je požádán, aby uvedl vnímané potíže se zvednutím nohy na stupnici od 0 do 5 (0=není vůbec obtížné; 5=neschopnost zvednout nohu) a bolest na stupnici od 0 do 10 (0=žádná bolest; 10=nejhorší možná bolest).
Pokud jsou obtíže nebo bolest hodnoceny 1 nebo vyšší, test se opakuje s výzkumníkem, který zajišťuje vnější kompresi pánve.
Pokud jsou vnímané obtíže nebo hlášená bolest při stlačení nižší, test je považován za pozitivní na lumbopelvickou nestabilitu.
Test se poté opakuje na opačné končetině.
Ostatní jména:
Protokol je podobný testu ASLR s tím rozdílem, že účastník je instruován, aby udržoval zvednutou nohu nad zemí co nejdéle.
Pod lumbopelvickou oblast účastníka bude umístěna vzduchová manžeta s biofeedbackem, aby se vyhodnotil pohyb páteře/pánve.
Manžeta bude nafouknuta na 40 mm Hg a účastník bude instruován, aby během testu držel jehlu co nejblíže 40 mm Hg; nebudou poskytnuty žádné informace o tom, jak ovlivnit tlak v manžetě, ale během úkolu bude poskytována vizuální zpětná vazba tlaku v manžetě.
Hodnocení vnímané námahy (RPE) a bolesti bude od účastníků získáváno každých 30–60 sekund.
Selhání úlohy bude definováno jako výška paty ≤ 10 cm nebo změna tlaku v manžetě ≥ 20 mm Hg.
Budou testovány obě končetiny, ale v různých sezeních.
Pořadí testování končetin (dominantní vs. nedominantní) bude náhodné a vyvážené.
Dominance končetin bude hlášena sama.
K posouzení interrektiální vzdálenosti nad a pod pupkem bude použit ultrazvuk v reálném čase.
Účastníci budou hodnoceni pomocí snímků v režimu B vleže na zádech v klidu, vleže na zádech při zvedání hlavy a vleže na zádech při provádění rovného zvedání nohou.
Hlavní vyšetřovatel má školení a zkušenosti v oblasti muskuloskeletálního ultrazvuku.
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
Ostatní jména:
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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Aktivní komparátor: Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
|
ASLR test je dobře zavedený klinický test, který hodnotí stabilitu bederní páteře/pánve, závažnost zadní pánevní bolesti a schopnost aktivovat břišní svaly.
Provádí se vleže.
Účastníci jsou instruováni, aby zvedli jednu nohu s rovným kolenem do výšky paty 20 cm.
Noha je držena nahoře po dobu 5 sekund, poté pomalu spuštěna na zem.
Účastník je požádán, aby uvedl vnímané potíže se zvednutím nohy na stupnici od 0 do 5 (0=není vůbec obtížné; 5=neschopnost zvednout nohu) a bolest na stupnici od 0 do 10 (0=žádná bolest; 10=nejhorší možná bolest).
Pokud jsou obtíže nebo bolest hodnoceny 1 nebo vyšší, test se opakuje s výzkumníkem, který zajišťuje vnější kompresi pánve.
Pokud jsou vnímané obtíže nebo hlášená bolest při stlačení nižší, test je považován za pozitivní na lumbopelvickou nestabilitu.
Test se poté opakuje na opačné končetině.
Ostatní jména:
Protokol je podobný testu ASLR s tím rozdílem, že účastník je instruován, aby udržoval zvednutou nohu nad zemí co nejdéle.
Pod lumbopelvickou oblast účastníka bude umístěna vzduchová manžeta s biofeedbackem, aby se vyhodnotil pohyb páteře/pánve.
Manžeta bude nafouknuta na 40 mm Hg a účastník bude instruován, aby během testu držel jehlu co nejblíže 40 mm Hg; nebudou poskytnuty žádné informace o tom, jak ovlivnit tlak v manžetě, ale během úkolu bude poskytována vizuální zpětná vazba tlaku v manžetě.
Hodnocení vnímané námahy (RPE) a bolesti bude od účastníků získáváno každých 30–60 sekund.
Selhání úlohy bude definováno jako výška paty ≤ 10 cm nebo změna tlaku v manžetě ≥ 20 mm Hg.
Budou testovány obě končetiny, ale v různých sezeních.
Pořadí testování končetin (dominantní vs. nedominantní) bude náhodné a vyvážené.
Dominance končetin bude hlášena sama.
K posouzení interrektiální vzdálenosti nad a pod pupkem bude použit ultrazvuk v reálném čase.
Účastníci budou hodnoceni pomocí snímků v režimu B vleže na zádech v klidu, vleže na zádech při zvedání hlavy a vleže na zádech při provádění rovného zvedání nohou.
Hlavní vyšetřovatel má školení a zkušenosti v oblasti muskuloskeletálního ultrazvuku.
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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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Average Total Activity Counts (TAC) per day over 7 days
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Physical activity levels via self-reported questionnaires
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Baseline and 7-14 days post-intervention
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Pelvic floor muscle endurance
Časové okno: Baseline and 7-14 days post-intervention
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Root mean square (RMS) of global EMG
Časové okno: 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)
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Rita Deering, DPT, PhD, Carroll University
- Ředitel studie: Kimberly Klug, DSc, Carroll University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
19. února 2026
Primární dokončení (Odhadovaný)
Primární dokončení
1. května 2028
Dokončení studie (Odhadovaný)
Dokončení studie
1. srpna 2028
Termíny zápisu do studia
První předloženo
První předloženo
20. listopadu 2025
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
21. května 2026
První zveřejněno (Aktuální)
První zveřejněno
29. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. května 2026
Naposledy ověřeno
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 2025-061
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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).
Časový rámec sdílení IPD
Data will be made available following completion of data collection.
Data will be shared for as long as possible per DASH guidelines.
Kritéria přístupu pro sdílení 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Aktivní test zvedání rovné nohy
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NCT04485572DokončenoRadikulopatie, lumbosakrální oblast