- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07613333
Postpartum Exercise Intervention
2026년 5월 21일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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).
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Rita Deering, DPT, PhD
- 전화번호: 2629513047
- 이메일: deeringresearch@carrollu.edu
연구 장소
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Wisconsin
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Waukesha, Wisconsin, 미국, 53186
- 모병
- Carroll University Center for Graduate Studies
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연락하다:
- Rita E Deering, DPT, PhD
- 전화번호: 2629513047
- 이메일: rdeering@carrollu.edu
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연락하다:
- Kimberly Klug, PT, DSc
- 이메일: kklug@carrollu.edu
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수석 연구원:
- Rita E Deering, DPT, PhD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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 검사는 요추/골반의 안정성, 골반 후방 통증의 정도, 복근 활성화 능력을 평가하는 잘 정립된 임상 검사입니다.
그것은 앙와위에서 수행됩니다.
참가자는 무릎을 곧게 편 상태에서 한쪽 다리를 들어 뒤꿈치 높이가 20cm가 되도록 지시를 받습니다.
다리는 5초 동안 위쪽에서 유지한 다음 천천히 바닥으로 내립니다.
참가자는 다리를 들어 올리는 데 인지된 어려움을 0~5 척도(0=전혀 어렵지 않음, 5=다리를 들어 올릴 수 없음) 및 통증을 0~10 척도(0=통증 없음, 10=가장 심함)로 보고하도록 요청받습니다. 가능한 고통).
어려움이나 통증이 1 이상으로 평가되면 연구원이 골반의 외부 압박을 제공하여 테스트를 반복합니다.
인지된 어려움이나 보고된 통증이 압박으로 인해 낮아지면 검사는 요골반 불안정성에 대해 양성으로 간주됩니다.
그런 다음 반대쪽 사지에서 테스트를 반복합니다.
다른 이름들:
이 프로토콜은 ASLR 테스트와 유사하지만 참가자가 가능한 한 오랫동안 지면에서 높은 다리를 유지하도록 지시된다는 점만 다릅니다.
척추/골반의 움직임을 평가하기 위해 참가자의 요골반 부위 아래에 바이오피드백 에어 커프를 배치합니다.
커프는 40mmHg로 팽창되고 참가자는 테스트 내내 바늘을 가능한 한 40mmHg에 가깝게 유지하도록 지시합니다. 커프 압력에 영향을 미치는 방법에 대한 정보는 제공되지 않지만 작업 전반에 걸쳐 커프 압력에 대한 시각적 피드백이 제공됩니다.
30-60초마다 참가자로부터 인지된 운동(RPE) 및 통증 등급을 얻습니다.
작업 실패는 뒤꿈치 높이가 10cm 이하이거나 커프 압력이 20mmHg 이상 변화하는 것으로 정의됩니다.
양쪽 사지가 테스트되지만 다른 세션에서 테스트됩니다.
사지 테스트의 순서(우세 vs 비우세)는 무작위로 조정되고 균형을 맞춥니다.
사지 우세는 자가 보고됩니다.
실시간 초음파는 배꼽 위와 아래의 직근간 거리를 평가하는 데 사용됩니다.
참가자는 휴식 시 누운 자세, 머리를 들어 올린 상태의 누운 자세, 똑바로 다리를 들어 올리는 동안 누운 자세의 B 모드 이미지로 평가됩니다.
주임연구원은 근골격계 초음파에 대한 교육과 경험이 있습니다.
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
다른 이름들:
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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활성 비교기: Control
Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.
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ASLR 검사는 요추/골반의 안정성, 골반 후방 통증의 정도, 복근 활성화 능력을 평가하는 잘 정립된 임상 검사입니다.
그것은 앙와위에서 수행됩니다.
참가자는 무릎을 곧게 편 상태에서 한쪽 다리를 들어 뒤꿈치 높이가 20cm가 되도록 지시를 받습니다.
다리는 5초 동안 위쪽에서 유지한 다음 천천히 바닥으로 내립니다.
참가자는 다리를 들어 올리는 데 인지된 어려움을 0~5 척도(0=전혀 어렵지 않음, 5=다리를 들어 올릴 수 없음) 및 통증을 0~10 척도(0=통증 없음, 10=가장 심함)로 보고하도록 요청받습니다. 가능한 고통).
어려움이나 통증이 1 이상으로 평가되면 연구원이 골반의 외부 압박을 제공하여 테스트를 반복합니다.
인지된 어려움이나 보고된 통증이 압박으로 인해 낮아지면 검사는 요골반 불안정성에 대해 양성으로 간주됩니다.
그런 다음 반대쪽 사지에서 테스트를 반복합니다.
다른 이름들:
이 프로토콜은 ASLR 테스트와 유사하지만 참가자가 가능한 한 오랫동안 지면에서 높은 다리를 유지하도록 지시된다는 점만 다릅니다.
척추/골반의 움직임을 평가하기 위해 참가자의 요골반 부위 아래에 바이오피드백 에어 커프를 배치합니다.
커프는 40mmHg로 팽창되고 참가자는 테스트 내내 바늘을 가능한 한 40mmHg에 가깝게 유지하도록 지시합니다. 커프 압력에 영향을 미치는 방법에 대한 정보는 제공되지 않지만 작업 전반에 걸쳐 커프 압력에 대한 시각적 피드백이 제공됩니다.
30-60초마다 참가자로부터 인지된 운동(RPE) 및 통증 등급을 얻습니다.
작업 실패는 뒤꿈치 높이가 10cm 이하이거나 커프 압력이 20mmHg 이상 변화하는 것으로 정의됩니다.
양쪽 사지가 테스트되지만 다른 세션에서 테스트됩니다.
사지 테스트의 순서(우세 vs 비우세)는 무작위로 조정되고 균형을 맞춥니다.
사지 우세는 자가 보고됩니다.
실시간 초음파는 배꼽 위와 아래의 직근간 거리를 평가하는 데 사용됩니다.
참가자는 휴식 시 누운 자세, 머리를 들어 올린 상태의 누운 자세, 똑바로 다리를 들어 올리는 동안 누운 자세의 B 모드 이미지로 평가됩니다.
주임연구원은 근골격계 초음파에 대한 교육과 경험이 있습니다.
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average Total Activity Counts (TAC) per day over 7 days
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Root mean square (RMS) of global EMG
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Rita Deering, DPT, PhD, Carroll University
- 연구 책임자: Kimberly Klug, DSc, Carroll University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 19일
기본 완료 (추정된)
2028년 5월 1일
연구 완료 (추정된)
2028년 8월 1일
연구 등록 날짜
최초 제출
2025년 11월 20일
QC 기준을 충족하는 최초 제출
2026년 5월 21일
처음 게시됨 (실제)
2026년 5월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 21일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-061
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data will be archived in the NICHD Data and Specimen Hub (DASH).
Per the DASH protocol, study data will be assigned a digital object identifier (DOI).
Data will also be able to be found via searching for keywords (e.g., postpartum exercise).
IPD 공유 기간
Data will be made available following completion of data collection.
Data will be shared for as long as possible per DASH guidelines.
IPD 공유 액세스 기준
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
신체 활동에 대한 임상 시험
-
Centre Hospitalier Universitaire de la Réunion아직 모집하지 않음선천성 심장 질환 | 미분획 헤파린 | Anti Xa Activity
-
University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스