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ExerciseNCT03838146

Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics

A study testing Types of Exercise in people with Exercise, run by East Carolina University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.[1, 2] Insulin resistance in skeletal muscle is believed to be a… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Exercise
What is being tested?
Types of Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteUnited States
Study dates
1 Sep 2018to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

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 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • <16 weeks gestation
  • singleton pregnancy telephone/email contact

Who cannot join

  • chronic conditions i.e. diabetes, hypertension, HIV, etc.
  • use of medications that affect fetal development;
  • use of alcohol, tobacco, or other drugs

Trial locations and contacts

1 site in 1 country.

United States1 site
  • East Carolina University

    Greenville, North Carolina, 27834

Other trials in United States

About this study

The American Heart Association suggests that heart disease prevention should target pregnancy and the first year of life; however, there is a fundamental gap in knowledge regarding the effects of prenatal exercise on the prevention of heart disease.[1, 2] Insulin resistance in skeletal muscle is believed to be a critical contributor to the metabolic syndrome which increases the risk for cardiovascular disease (CVD). Conversely, exercise improves insulin sensitivity and many other facets of skeletal muscle function and metabolism; however, it is unclear if this positive effect can be "imprinted" in the skeletal muscle of the fetus with maternal exercise and accordingly diminish CVD risk in offspring. Our previous studies found that exercise during pregnancy leads to improved heart measures and reduced adiposity.[3-6] These studies demonstrated the potential for maternal exercise to reduce risk for CVD, but the cellular mechanisms involved, however, are not clearly evident. The proposed project will fill this critical gap and assess the influence of maternal exercise intervention to "imprint" progenitor stem cells in the fetus (umbilical cord tissue) to develop into insulin sensitive skeletal muscle and also improve indices of infant morphometry and movement. Using a randomized design, 160 women will perform either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk. The investigators will test the central hypothesis that exercise during pregnancy alters skeletal muscle in a manner which decreases the risk of heart disease in offspring. To test this central hypothesis, the investigators will pursue two specific aims: Aim 1- Determine the ability of regular maternal exercise to imprint key myocellular metabolic (insulin sensitivity) properties of offspring mesenchymal stem cells (MSC), neuromotor function, and morphometry. Aim 2- Determine the distinct abilities of regular maternal exercise to imprint the metabolome of offspring MSC.

Read the detailed description

Is offspring skeletal muscle function and metabolism imprinted by regular maternal exercise? What offspring metabolome markers are altered with regular maternal exercise? The investigators will use a randomized design of 160 women to either exercise intervention (aerobic training, resistance training, or both) or usual care (controls). Infant cord tissue and blood will be sampled at birth while blood will be sampled at 1 month of age. Similarly, infant neuromotor and morphometric examinations will be performed at 1 month. and at 1-month of age via blood sample, neuromotor, and morphometric examinations. The rationale for the project is to elucidate the effects of maternal exercise on offspring health outcomes and determine specific metabolic targets predictive of offspring long-term disease risk.

Conditions
Exercise
Being tested
Types of 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.

  • Types of ExerciseBehavioural

    moderate intensity exercise

Study groups in NCT03838146
Study groupRoleWhat they receive
Non-Exercise ControlNo interventionThis group will come in regularly for measurements, but will not have an exercise intervention. If necessary for retention of participants, then we will meet with controls 3 times a week to stress reduction techniques.
Resistance Type of ExerciseExperimentalThis group will participate in resistance exercise intervention 3 times per week from enrollment to delivery.The resistance training (RT) group will perform three sets of 12-15 repetitions of 10-12 resistance exercises in a circuit, with rest of 30-60 seconds between sets as needed. Participants will use a combination of Cybex machines (Cybex International, Medway, MA), resistance bands, and free weights. Routines will change every 3 weeks to add variety and improve compliance.
Receives: Behavioral: Types of Exercise
Combination Type of ExerciseExperimentalThis group will participate in combination (aerobic+resistance) exercise intervention 3 times per week from enrollment to delivery. The combination (CT) group will alternate between resistance and aerobic exercises. Participants will perform 4.5 minute bouts of aerobic exercise and perform four resistance exercises of 12-15 repetition that vary between aerobic bouts[17-19]. The aerobic exercise bouts will be performed on the aerobic machine of the participant's choosing as described above. The resistance routine will follow similar guidelines as the resistance group.
Receives: Behavioral: Types of Exercise
Aerobic Type of ExerciseExperimentalThis group will participate in aerobic exercise intervention 3 times per week from enrollment to delivery. The aerobic training (AT) group will perform a continuous aerobic exercise of their choosing (e.g., treadmill, ellipticals, stairs, Zumba, or outside walking/jogging). Participants' ability to choose an aerobic activity that they are comfortable with and enjoy is intended to improve compliance.
Receives: Behavioral: Types of Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured

    Western blot analysis of Akt phosphorylation will be conducted on cell lysates from myotubes under basal or following insulin-stimulation. Glycogen synthesis will be measured under basal and insulin-stimulated conditions. Data will be presented as % change in glycogen synthesis following insulin stimulation.

    Measured: At Birth

Secondary outcomes (4)
  1. Global and targeted metabolomics analysis will be conducted to map out pathways and mechanisms from regular maternal exercise. Docosahexaenoic acid (DHA), Eicosapentaenoic Acid (EPA), Docosapentaenoic Acid (DPA), and Arachidonic acid (ARA).

    Targeted quantitative LC/MS analysis of DHA and EPA from participants at 16 (pre-training intervention) and 36 weeks, DHA and EPA levels from umbilical cord tissue sample, and DHA and EPA levels from umbilical cord (infant) blood will be compared between groups.

    From our pathway analysis of identified metabolites of interest, we will be able to map the metabolites of interest within common pathways related to maternal exercise exposure.

    Measured: At 16 weeks and 36 weeks gestation

  2. Peabody Developmental Motor Scales, 2nd edition (PDMS-2) will be performed by a pediatric physical therapist (blinded to group classification) to measure gross motor skills of infants up to 12 months of age.

    3 of the 6 subtests can be used on 1 month olds. All items scored from 0-2, which include:

    1. Reflexes: 8-item subtest that measures child's ability to react to environmental events.
    2. Stationary: 30-item subtest that measures child's ability to control body within center of gravity and retain equilibrium
    3. Locomotion: 89-item subtest that measures child's ability to move from one place to another through crawling, walking, running, hopping, and jumping forward we only do the Reflexes Range (0-16), Stationary Range (0-60), and Locomotion Range (0-178) subtests. Each subtest score is also converted to percentile (comparing infant's behavior to the normative sample). All subtest score are summed to determine the Gross Motor Quotient (GMQ), and a GMQ percentile score will be determined.

    Measured: at 1 month postnatal visit

  3. A trained (blinded) researcher will measure bicep, tricep, and subscapular skinfold measures, circumferences (abdominal, head, mid-upper arm), and lengths (body, femur, leg, humeral). All measures are recorded as mm.

    All measures will be taken in duplicate on the right side following published standards for skinfold and circumference location.

    Data will be used to compare individual skinfolds, sum of skinfolds and circumferences measures between groups

    Measured: at 1 month postnatal visit

  4. A trained (blinded) researcher will measure body weight on an infant scale

    Body weight will be done to the nearest tenth of a kilogram. Data will be used to compare body weight measures between groups

    Measured: at 1 month postnatal visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start1 Sep 2018
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
comparing 3 exercise interventions to a control (non-exercise) group
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03838146
Sponsor's protocol ID
12-002524b
Status last verified
Aug 2023
First submitted
5 Nov 2018
Last updated
8 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: we will not be sharing individual data with other researchers

Publications

  • Jevtovic F, Wisseman BL, Jahan F, Claiborne A, Collier DN, DeVente JE, Mouro S, Zeczycki T, Szumilewicz A, Adamo KB, Goodyear LJ, May LE. Maternal exercise alters placental proteome in an exercise mode-specific manner. Am J Physiol Endocrinol Metab. 2025 Dec 1;329(6):E912-E922. doi: 10.1152/ajpendo.00052.2025. Epub 2025 Nov 4.

    PubMed 41187954
  • Sanchez-Parente S, Kern K, Claiborne A, Wisseman B, Steen D, Roenker B, Lilley A, Strom C, Newton E, DeVente J, Mouro S, Collier D, Kuehn D, Dubose KD, Kelley G, McMillan AG, Castro-Pinero J, Aparicio VA, May LE. Impact of Supervised-concurrent Exercise During Pregnancy on Infant Neuromotor Skills: A Post-hoc Analysis Stratified by Maternal BMI. Sports Med Open. 2025 Jun 20;11(1):78. doi: 10.1186/s40798-025-00886-x.

    PubMed 40542229
  • Jevtovic F, Claiborne A, DeVente JE, Mouro S, Houmard JA, Broskey NT, May LE. Maternal resistance exercise increases infant energy expenditure. Am J Physiol Endocrinol Metab. 2025 Mar 1;328(3):E354-E361. doi: 10.1152/ajpendo.00414.2024. Epub 2024 Dec 23.

    PubMed 39716848
  • Jevtovic F, Claiborne A, Biagioni EM, Collier DN, DeVente JE, Mouro S, Kaneko-Tarui T, O-Tierney-Ginn PF, Goodyear LJ, Houmard JA, Broskey NT, May LE. Paternal obesity decreases infant MSC mitochondrial functional capacity. Am J Physiol Endocrinol Metab. 2024 Oct 1;327(4):E441-E448. doi: 10.1152/ajpendo.00239.2024. Epub 2024 Aug 14.

    PubMed 39140975
  • Jevtovic F, Collier DN, DeVente J, Mouro S, Claiborne A, Wisseman B, Steen D, Kern K, Broskey N, May LE. Maternal exercise increases infant resting energy expenditure: preliminary results. Int J Obes (Lond). 2024 Sep;48(9):1347-1350. doi: 10.1038/s41366-024-01560-0. Epub 2024 Jun 10.

    PubMed 38858465
  • Jevtovic F, Zheng D, Houmard JA, Kern K, Claiborne A, Lopez CA, Broskey NT, Isler C, DeVente J, Newton E, May LE. Myogenically differentiated mesenchymal stem cell insulin sensitivity is associated with infant adiposity at 1 and 6 months of age. Obesity (Silver Spring). 2023 Sep;31(9):2349-2358. doi: 10.1002/oby.23829. Epub 2023 Aug 8.

    PubMed 37551412
  • Jevtovic F, Zheng D, Houmard JA, Krassovskaia PM, Lopez CA, Wisseman BL, Steen DM, Broskey NT, Isler C, DeVente J, Fang X, May LE. Effects of Maternal Exercise Modes on Glucose and Lipid Metabolism in Offspring Stem Cells. J Clin Endocrinol Metab. 2023 Jun 16;108(7):e360-e370. doi: 10.1210/clinem/dgad059.

    PubMed 36722208
  • McDonald SM, Mouro S, Wisseman B, Isler C, DeVente J, Newton E, Hildebrand J, Kuehn D, Kelley G, Chasan-Taber L, Broskey NT, May LE. Influence of prenatal exercise on the relationship between maternal overweight and obesity and select delivery outcomes. Sci Rep. 2022 Oct 15;12(1):17343. doi: 10.1038/s41598-022-22283-0.

    PubMed 36243785

Questions about this trial

What is this clinical trial studying?

A study testing Types of Exercise in people with Exercise, run by East Carolina 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 3 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: finished, as of the sponsor's last update on 8 Aug 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured (time frame: At Birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03838146, which also lists 8 linked publications.

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 8 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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