Clinical trial NCT05073224: Muscle Function After Childbirth
Official title: Neuromuscular Biomechanics of the Lumbopelvic Stabilizing Muscles in Nulligravid and Postpartum Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum
Muscle Fatigue
Force Steadiness
Nulligravid
Muscle Weakness
Lead sponsor: Carroll University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.

Detailed description: Stability of the lumbar spine and pelvis is essential to nearly all activities of daily living, and is achieved primarily by muscular stabilization. Recent studies have shown that postpartum women are more fatigable than nulligravid women during fatiguing tasks with the lumbopelvic stabilizing muscles (23%) and the trunk flexor muscles (52%) at six months postpartum. Postpartum women also demonstrate impaired control of force with the trunk flexor muscles; however, it is unknown if force control during a fatiguing task of the lumbopelvic stabilizing muscles is impaired in postpartum women.

This study has 3 purposes: (1) To quantify limb steadiness during fatiguing exercise of the lumbopelvic stabilizing muscles among nulligravid women and postpartum women; (2) to quantify muscle activity in the trunk, test limb and contralateral limb to provide insight into motor control; and (3) to identify possible factors (inter-recti distance (IRD), physical activity, pain, biopsychosocial factors) that contribute to neuromuscular function (fatigability and force control).

This is a novel, translational study that, for the first time, will quantify lower extremity force control in postpartum women. As this has not been studied before, to the best of the investigators' knowledge, this proposal will be a pilot study to establish means to utilize in power analyses for future studies of larger magnitude. Furthermore, neuromuscular function is not typically assessed clinically in postpartum women, and no tests exist to easily assess fatigability of the lumbopelvic stabilizing muscles in clinic settings. This study will also provide further data to highlight the ASLR Fatigue Task as a possible clinical examination tool and outcome measure to assess fatigability of the lumbopelvic stabilizing muscles.

Eligibility criteria: Inclusion Criteria:

* Post-partum
* Primiparous (this is their first child)

Exclusion Criteria:

* multiple gestation
* prescription anti-inflammatory/pain medications that are taken daily
* significant orthopedic conditions that would contraindicate performance of the fatigue task (such as fractures, severe scoliosis, etc)
* cardiovascular \& pulmonary disease
* neuromuscular health conditions (such as diabetes, neuropathy, multiple sclerosis, stroke, seizures, etc)
* history of previous abdominal surgery (with the exception of Cesarean delivery)

Nulligravid Women (Controls)

* Women from the surrounding community will also be recruited to serve as controls
* Nulligravid women will meet the same inclusion/exclusion criteria as the postpartum women, with the exception of never having been pregnant

Primary outcomes:
measure: Incidence of Posterior Pelvic Pain
timeFrame: up to 10 days
measure: Incidence of Perceived Difficulty with ASLR Task
timeFrame: up to 10 days
measure: Incidence of Lumbopelvic Instability
timeFrame: up to 10 days
measure: Mean Time to ASLR Fatigue Task Failure
timeFrame: up to 10 days
measure: Maximum Lower Extremity Strength: Leg
timeFrame: up to 10 days
measure: Maximum Lower Extremity Strength: Hip Extension
timeFrame: up to 10 days
measure: Limb Steadiness Measured by Limb Acceleration
timeFrame: up to 10 days
measure: Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance
timeFrame: up to 10 days
Secondary outcomes:
measure: Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)
timeFrame: up to 10 days
measure: Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score
timeFrame: up to 10 days
measure: Average Total Activity Counts (TAC) per day over 7 days
timeFrame: up to 7 days
measure: Physical Activity Measured by Average Steps per day over 7 days
timeFrame: up to 7 days
measure: Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: tri-axial counts
timeFrame: up to 7 days
measure: Mean Duration per day of Moderate-Vigorous Physical Activity (MVPA) over 7 days: vertical counts
timeFrame: up to 7 days
measure: Average Minutes per Day of Activity in at least 5-minute bouts
timeFrame: up to 7 days
measure: Average Minutes per Day of Activity in at least 10-minute bouts
timeFrame: up to 7 days
measure: Percent Change in Global Surface EMG Recordings: Abdominal Muscles
timeFrame: up to 10 days
measure: Percent Change in Global Surface EMG Recordings: Rectus femoris
timeFrame: up to 10 days
measure: Mean Global Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: up to 10 days
measure: Mean Pelvic Floor Distress Inventory Short Form (PFDI-20) Score
timeFrame: up to 10 days
measure: Mean Oswestry Disability Index Score
timeFrame: up to 10 days
measure: Mean Pain Catastrophizing Scale (PCS) Score
timeFrame: up to 10 days
measure: Mean Edinburgh Postnatal Depression Scale (EPDS) Score
timeFrame: up to 10 days
measure: Mean Post Traumatic Stress Disorder (PTSD) Score
timeFrame: up to 10 days
measure: Mean Tampa Scale for Kinesiophobia (TSK) Score
timeFrame: up to 10 days
measure: Mean Pelvic Girdle Questionnaire (PGQ) Score
timeFrame: up to 10 days
Other outcomes:
measure: Root mean square (RMS) of global EMG
timeFrame: up to 10 days
measure: Percent of Maximum Voluntary Isometric Contraction (MVIC)
timeFrame: up to 10 days
measure: Mean discharge rate of single motor units
timeFrame: up to 10 days
Locations:
city: Waukesha
country: United States
facility: Carroll University
state: Wisconsin
city: Waukesha
country: United States
facility: Carroll University
state: Wisconsin
Study officials:
affiliation: Carroll University
name: Rita Deering, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: