PostpartumNCT07613333
Postpartum Exercise Intervention
A study testing Progressive exercise, Active Straight Leg Raise Test and Active Straight Leg Raise Fatigue Task in people with Postpartum and Neuromuscular Adaptations, run by Carroll University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, Neuromuscular Adaptations, Abdominal Muscles
- What is being tested?
- Progressive exercise, Active Straight Leg Raise Test and Active Straight Leg Raise Fatigue Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- gave birth in the 24 months prior to study enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carroll University Center for Graduate Studies
Waukesha, Wisconsin, 53186
Rita E Deering, DPT, PhD, 2629513047, rdeering@carrollu.edu
Kimberly Klug, PT, DSc, kklug@carrollu.edu
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Postpartum, Neuromuscular Adaptations, Abdominal Muscles, Pelvic Floor Dysfunctions, Physical Activity
- Being tested
- Progressive exercise, Active Straight Leg Raise Test, Active Straight Leg Raise Fatigue Task, Lower Extremity Strength Testing, Ultrasound imaging of abdominal wall
- Keywords
- postpartum physical activity, postpartum neuromuscular function, postpartum exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive exerciseOther
Also called Exercise
A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
Active Straight Leg Raise TestDiagnostic test
Also called ASLR Test
The ASLR test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb.
Active Straight Leg Raise Fatigue TaskOther
The protocol is similar to the ASLR test, except that the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff will be placed under the participant's lumbopelvic region to assess movement of the spine/pelvis. The cuff will be inflated to 40 mm Hg, and the participant instructed to keep the needle as close to 40 mm Hg as possible throughout the test; no information will be provided on how to affect cuff pressure, but visual feedback of cuff pressure will be provided throughout the task. Ratings of perceived exertion (RPE) and pain will be obtained from participants every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested, but in different sessions. The order of limb testing (dominant vs non-dominant) will be randomized and counter-balanced. Limb dominance will be self-reported.
Lower Extremity Strength TestingOther
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.
Ultrasound imaging of abdominal wallDiagnostic test
Real time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise. The Principle Investigator has training and experience in musculoskeletal ultrasound.
Pelvic Floor Muscle Strength TestingOther
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 TestingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks. Receives: Other: Progressive exercise; Diagnostic Test: Active Straight Leg Raise Test; Other: Active Straight Leg Raise Fatigue Task; Other: Lower Extremity Strength Testing; Diagnostic Test: Ultrasound imaging of abdominal wall; Other: Pelvic Floor Muscle Strength Testing; Other: Pelvic Floor Muscle Endurance Testing |
| Control | Active comparator | Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels. Receives: Diagnostic Test: Active Straight Leg Raise Test; Other: Active Straight Leg Raise Fatigue Task; Other: Lower Extremity Strength Testing; Diagnostic Test: Ultrasound imaging of abdominal wall; Other: Pelvic Floor Muscle Strength Testing; Other: Pelvic Floor Muscle Endurance Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Total Activity Counts (TAC) per day over 7 days
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.
Measured: 7 days pre-intervention, 7 days post-intervention
Physical Activity Measured by Average Steps per day over 7 days
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.
Measured: 7 days pre-intervention, 7 days post-intervention
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
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.
Measured: 7 days pre-intervention, 7 days post-intervention
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
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).
Measured: 7 days pre-intervention, 7 days post-intervention
Average Minutes per Day of Activity in at least 5-minute bouts
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)
Measured: 7 days pre-intervention, 7 days post-intervention
Average Minutes per Day of Activity in at least 10-minute bouts
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)
Measured: 7 days pre-intervention, 7 days post-intervention
Physical activity levels via self-reported questionnaires
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.
Measured: Once-a-week for the 8-week intervention period
Lower extremity strength
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.
Measured: Baseline and 7-14 days post-intervention
Mean Time to ASLR Fatigue Task Failure
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.
Measured: Baseline and 7-14 days post-intervention
Pelvic floor muscle strength
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.
Measured: Baseline and 7-14 days post-intervention
Pelvic floor muscle endurance
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.
Measured: Baseline and 7-14 days post-intervention
Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
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.
Measured: Baseline and 7-14 days post-intervention
Fear of movement
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.
Measured: Baseline and 7-14 days post-intervention
Overall quality of life
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.
Measured: Baseline and 7-14 days post-intervention
Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
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.
Measured: Baseline and 7-14 days post-intervention
Inter-recti distance
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.
Measured: Baseline and 7-14 days post-intervention
Secondary outcomes (3)
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
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.
Measured: Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Abdominal Muscles
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.
Measured: Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Rectus femoris
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.
Measured: Baseline and 7-14 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start19 Feb 2026
- Primary completionMay 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial with parallel intervention and control groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carroll University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Deering, Carroll University
- Investigators
- Rita Deering, DPT, PhD, Principal investigator, Carroll UniversityKimberly Klug, DSc, Study director, Carroll University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613333
- Sponsor's protocol ID
- 2025-061
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Supervised Postpartum Exercise Program on Maternal Physical Activity Levels and Musculoskeletal Health
- ClinicalTrials.gov ID
- NCT07613333
- Acronym / sponsor ID
- 2025-061
- Conditions
- Postpartum, Neuromuscular Adaptations, Abdominal Muscles, Pelvic Floor Dysfunctions, Physical Activity
- Keywords
- postpartum physical activity, postpartum neuromuscular function, postpartum exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carroll UniversityUniversity, hospital or other
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial with parallel intervention and control groups
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Progressive exercise, Diagnostic Test: Active Straight Leg Raise Test, Other: Active Straight Leg Raise Fatigue Task, Other: Lower Extremity Strength Testing, Diagnostic Test: Ultrasound imaging of abdominal wall, Other: Pelvic Floor Muscle Strength Testing, Other: Pelvic Floor Muscle Endurance TestingStudy participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks. |
| Control | Active comparator | Diagnostic Test: Active Straight Leg Raise Test, Other: Active Straight Leg Raise Fatigue Task, Other: Lower Extremity Strength Testing, Diagnostic Test: Ultrasound imaging of abdominal wall, Other: Pelvic Floor Muscle Strength Testing, Other: Pelvic Floor Muscle Endurance TestingStudy participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- gave birth in the 24 months prior to study enrollment
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive exerciseAlso: ExerciseA progressive, 8-week exercise intervention has been developed and will be administered in a group setting. | Other | Exercise Intervention |
| Active Straight Leg Raise TestAlso: ASLR TestThe ASLR test is a well-established clinical test that assesses stability of the lumbar spine/pelvis, posterior pelvic pain severity, and ability to activate the abdominal muscles. It is performed in supine. Participants are instructed to raise one leg, with the knee straight, to a heel height of 20 cm. The leg is held at the top for 5 seconds, then slowly lowered to the ground. The participant is asked to report perceived difficulty to raise the leg on a 0 to 5 scale (0=not at all difficult; 5=unable to lift leg) and pain on a 0 to 10 scale (0=no pain; 10=worst possible pain). If difficulty or pain are rated at a 1 or higher, the test is repeated with the researcher providing external compression of the pelvis. If perceived difficulty or reported pain are lower with compression, the test is considered positive for lumbopelvic instability. The test is then repeated on the opposite limb. | Diagnostic test | Control, Exercise Intervention |
| Active Straight Leg Raise Fatigue TaskThe protocol is similar to the ASLR test, except that the participant is instructed to maintain the elevated leg off the ground for as long as possible. A biofeedback air cuff will be placed under the participant's lumbopelvic region to assess movement of the spine/pelvis. The cuff will be inflated to 40 mm Hg, and the participant instructed to keep the needle as close to 40 mm Hg as possible throughout the test; no information will be provided on how to affect cuff pressure, but visual feedback of cuff pressure will be provided throughout the task. Ratings of perceived exertion (RPE) and pain will be obtained from participants every 30-60 seconds. Task failure will be defined as a heel height ≤10 cm or a change in cuff pressure ≥20 mm Hg. Both limbs will be tested, but in different sessions. The order of limb testing (dominant vs non-dominant) will be randomized and counter-balanced. Limb dominance will be self-reported. | Other | Control, Exercise Intervention |
| Lower Extremity Strength TestingA 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. | Other | Control, Exercise Intervention |
| Ultrasound imaging of abdominal wallReal time ultrasound will be used to assess inter-recti distance above and below the umbilicus. Participants will be assessed with B Mode images in supine at rest, in supine while lifting their head, and in supine while performing a straight leg raise. The Principle Investigator has training and experience in musculoskeletal ultrasound. | Diagnostic test | Control, Exercise Intervention |
| Pelvic Floor Muscle Strength TestingAn 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). | Other | Control, Exercise Intervention |
| Pelvic Floor Muscle Endurance TestingPelvic 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. | Other | Control, Exercise Intervention |
Primary outcome
Average Total Activity Counts (TAC) per day over 7 days
Time frame: 7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring the TAC per day. TAC is the total number of filtered, full-wave rectified, integrated accelerations (all directions). These will then be averaged/day based on the total number of valid wear days for each participant.
Physical Activity Measured by Average Steps per day over 7 days
Time frame: 7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean steps per day. This will be quantified as reported by the Ametris (formerly ActiGraph) accelerometer and CentrePoint analysis software. The Algorithm used by Ametris is not publicly available, but Ametris/ActiGraph accelerometers are frequently used in research quantifying physical activity.
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
Time frame: 7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA. Intensity of physical activity assessed using tri-axial counts (per the accelerometer software) are as follows: Light physical activity is between 200 and 2690 counts/min, moderate intensity between 2690-6166 counts/min, and vigorous intensity is ≥ 6167 counts/min. MVPA is ≥2690.
Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
Time frame: 7 days pre-intervention, 7 days post-intervention
Physical activity habits around the time of testing will be assessed with a tri-axial accelerometer for 7 days outside of the laboratory, in part by measuring mean duration per day of MVPA. Intensity of physical activity assessed using vertical counts (per the accelerometer software) are as follows: Light physical activity is between 100 and 759 counts/min, moderate intensity is 760-5999 counts/min, and vigorous intensity is ≥ 6000 counts/min (MVPA is > 760 counts/min).
Average Minutes per Day of Activity in at least 5-minute bouts
Time frame: 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)
Average Minutes per Day of Activity in at least 10-minute bouts
Time frame: 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)
Physical activity levels via self-reported questionnaires
Time frame: Once-a-week for the 8-week intervention period
Participants will complete the International Physical Activity Questionnaire (IPAQ) short-form. The IPAQ short-form quantifies physical activity (PA) over the previous week in 2 categories: low, moderate, or high activity; or metabolic equivalents (MET) minutes per week. High PA is categorized as (1)vigorous PA on at least 3 days/week with a combined minimum of at least 1500 MET minutes/week or (2) 7 days of cumulative PA of any intensity that sums to a minimum total of at least 3000 MET minutes/week. Moderate PA is categorized as (1) 3+ days of at least 30 minutes of vigorous PA, (2) 5+ days of moderate PA or walking at least 30 minutes/day, or (3) 5+ days of any level of PA that sums to a minimum of 600 MET minutes/week. Low physical activity is categorized as activity that does not meet the criteria for medium or high activity.
Lower extremity strength
Time frame: Baseline and 7-14 days post-intervention
A straight leg raise maximal voluntary contraction (MVC) of each lower extremity will be performed in supine before and within 2 minutes of completing the ASLR fatigue task with a custom made load cell instrumented strength testing device. This device consists of a rigid platform on which the study participant will lie supine. At the foot of the device is a tower that houses 2 load cells and is connected to a lightly padded push plate. This push plate can be raised and lowered such that the participant can push up into the plate (contacts the anterior surface of the participant's shin) or push down onto the push plate (contacts the posterior aspect of the participant's heel). Before the ASLR fatigue task, a minimum of 3 MVC trials will be performed on each leg, with a minimum of 1 minute rest between trials; the highest peak force will be considered the MVC. Only 1 MVC trial per leg will be performed following the fatigue task.
Mean Time to ASLR Fatigue Task Failure
Time frame: Baseline and 7-14 days post-intervention
The Active Straight Leg Raise Fatigue Task will be administered. Participants are asked to raise one leg to a heel height of 20 cm while lying supine. Participants are encouraged to keep the leg raised as long as possible. Task failure will be defined as a heel height less than or equal to 10 centimeters off the ground.
Pelvic floor muscle strength
Time frame: Baseline and 7-14 days post-intervention
An internal vaginal pelvic floor muscle assessment will be performed at baseline and study completion by a licensed physical therapist with advanced training in pelvic floor muscle examination and treatment. Pelvic floor muscle function will be assessed using the PERFECT scale, which assesses both muscular strength ("P" for "power") and endurance ("E"). Strength is assessed by cueing the participant to perform a maximal voluntary pelvic floor muscle contraction while the examiner has their index finger inserted into the vagina. The modified Oxford scale is used to grade strength on a scale of zero (0) to five (5) with 5 being the strongest.
Pelvic floor muscle endurance
Time frame: 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.
Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
Time frame: Baseline and 7-14 days post-intervention
The PFDI-20 is composed of 20 items total on three scales (Pelvic Organ Prolapse, Colorectal-Anal Distress, Urinary Distress), each scored on a 5 point likert scale. Mean scores from each scale are calculated and multiplied by 25, then added together for a total possible range of scores from 0-300. Higher scores indicate increased pelvic floor distress.
Fear of movement
Time frame: Baseline and 7-14 days post-intervention
Fear of movement (kinesiophobia) will be assessed via the Tampa Scale for Kinesiophobia (TSK). The TSK is a 17-question, self-administered questionnaire that utilizes a 4-point Likert scale (1= strongly agree, 4=strongly disagree). Total scores range from 17-68. A higher score indicates higher levels of kinesiophobia; a score of 17 indicates no/minimal kinesiophobia.
Overall quality of life
Time frame: 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.
Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: 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.
Inter-recti distance
Time frame: 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.
3 secondary outcomes
Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
Time frame: Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Abdominal Muscles
Time frame: Baseline and 7-14 days post-intervention
Percent Change in Global Surface EMG Recordings: Rectus femoris
Time frame: Baseline and 7-14 days post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Deering, DPT, PhD principal investigator
Carroll University
Kimberly Klug, DSc study director
Carroll University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive exercise, Active Straight Leg Raise Test and Active Straight Leg Raise Fatigue Task in people with Postpartum and Neuromuscular Adaptations, run by Carroll University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Deering, DPT, PhD (2629513047, deeringresearch@carrollu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Total Activity Counts (TAC) per day over 7 days (time frame: 7 days pre-intervention, 7 days post-intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.