Postpartum Exercise Intervention

NCT07613333 | Recruiting

• 1 other identifier: 2025-061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

postpartum physical activity; postpartum neuromuscular function; postpartum exercise

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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).

  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)

  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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Baseline and 7-14 days post-intervention

• Percent Change in Global Surface EMG Recordings: Abdominal Muscles

  Baseline and 7-14 days post-intervention

• Percent Change in Global Surface EMG Recordings: Rectus femoris

  Baseline and 7-14 days post-intervention

Other Outcomes (2)

• Root mean square (RMS) of global EMG

  Baseline and 7-14 days post-intervention

• Percent of Maximum Voluntary Isometric Contraction (MVIC)

  Baseline and 7-14 days post-intervention

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

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

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.

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

Interventions

Progressive exercise OTHER

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

Also known as: Exercise

Exercise Intervention

Active Straight Leg Raise Test DIAGNOSTIC_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.

Also known as: ASLR Test

Control; Exercise Intervention

Lower Extremity Strength Testing OTHER

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.

Control; Exercise Intervention

Ultrasound imaging of abdominal wall DIAGNOSTIC_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.

Control; Exercise Intervention

Pelvic Floor Muscle Strength Testing OTHER

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).

Control; Exercise Intervention

Active Straight Leg Raise Fatigue Task OTHER

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.

Control; Exercise Intervention

Pelvic Floor Muscle Endurance Testing OTHER

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.

Control; Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• gave birth in the 24 months prior to study enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Carroll University: lead

Study Sites (1)

Carroll University Center for Graduate Studies

Waukesha, Wisconsin, 53186, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rita Deering, DPT, PhD

  Carroll University

  PRINCIPAL INVESTIGATOR

• Kimberly Klug, DSc

  Carroll University

  STUDY DIRECTOR

Central Study Contacts

Rita Deering, DPT, PhD

CONTACT

2629513047; deeringresearch@carrollu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized control trial with parallel intervention and control groups

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: May 29, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available following completion of data collection. Data will be shared for as long as possible per DASH guidelines.
• Access Criteria: 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.

Locations

US (1)