Recruiting

Exercise Program

Sponsor:

Carroll University

Code:

NCT07613333

Conditions

Postpartum

Neuromuscular Adaptations

Abdominal Muscles

Pelvic Floor Dysfunctions

Physical Activity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Progressive exercise

Active Straight Leg Raise Test

Active Straight Leg Raise Fatigue Task

Lower Extremity Strength Testing

Ultrasound imaging of abdominal wall

Study Details

Brief 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. 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.

Conditions

Postpartum

Neuromuscular Adaptations

Abdominal Muscles

Pelvic Floor Dysfunctions

Physical Activity

Study ID

NCT07613333

Start date

Feb 19, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

Study participants will attend a 1-hour in-person group exercise intervention once a week for 8 weeks.

active comparator: Control

Study participants will not receive the exercise intervention but will complete a weekly questionnaire to self-report physical activity levels.

Interventions

Progressive exercise

A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.

Active Straight Leg Raise 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 Task

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 Testing

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 wall

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 Testing

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 Testing

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.

Primary outcome measure

  • Average Total Activity Counts (TAC) per day over 7 days [ Time Frame: 7 days pre-intervention, 7 days post-intervention ]
  • Physical Activity Measured by Average Steps per day over 7 days [ Time Frame: 7 days pre-intervention, 7 days post-intervention ]
  • 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 ]
  • 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 ]
  • Average Minutes per Day of Activity in at least 5-minute bouts [ Time Frame: 7 days pre-intervention, 7 days post-intervention ]
  • Average Minutes per Day of Activity in at least 10-minute bouts [ Time Frame: 7 days pre-intervention, 7 days post-intervention ]
  • Physical activity levels via self-reported questionnaires [ Time Frame: Once-a-week for the 8-week intervention period ]
  • Lower extremity strength [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Mean Time to ASLR Fatigue Task Failure [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Pelvic floor muscle strength [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Pelvic floor muscle endurance [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Fear of movement [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Overall quality of life [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Mean Global Pittsburgh Sleep Quality Index (PSQI) Score [ Time Frame: Baseline and 7-14 days post-intervention ]
  • Inter-recti distance [ Time Frame: Baseline and 7-14 days post-intervention ]

Central Contacts and Locations

Central contacts

Rita Deering, DPT, PhD

2629513047deeringresearch@carrollu.edu

Locations

Carroll University Center for Graduate Studies

Recruiting

Waukesha, Wisconsin, United States, 53186

Contacts

Rita E Deering, DPT, PhD

2629513047rdeering@carrollu.edu

Kimberly Klug, PT, DSc

kklug@carrollu.edu

Principal Investigator:

Rita E Deering, DPT, PhD

More Information

Sponsor

Carroll University

Last update posted

May 29, 2026

Last verified

Apr, 2026

Keywords

  • postpartum physical activity
  • postpartum neuromuscular function
  • postpartum exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Carroll University on 2026-05-29.