Postpartum Exercise Intervention

Official title

Influence of a Supervised Postpartum Exercise Program on Maternal Physical Activity Levels and Musculoskeletal Health

Overview

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).

Interventions

• Other Progressive exercise
  A progressive, 8-week exercise intervention has been developed and will be administered in a group setting.
• Diagnostic test 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=
• Other 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
• Other 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 pus
• Diagnostic test 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.
• Other 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
• Other 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 measures

• 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]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Carroll University Center for Graduate Studies — Waukesha

Identifiers

NCT: NCT07613333 · 2025-061

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗