- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838146
Influence of Maternal Exercise on Infant Skeletal Muscle and Metabolomics
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Greenville, North Carolina, United States, 27834
- East Carolina University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- <16 weeks gestation
- singleton pregnancy telephone/email contact
Exclusion Criteria:
- chronic conditions i.e. diabetes, hypertension, HIV, etc.
- use of medications that affect fetal development;
- use of alcohol, tobacco, or other drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Non-Exercise Control
This 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.
|
|
Experimental: Resistance Type of Exercise
This 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.
|
moderate intensity exercise
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Experimental: Combination Type of Exercise
This 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.
|
moderate intensity exercise
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Experimental: Aerobic Type of Exercise
This 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.
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moderate intensity exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Human Skeletal Muscles cells grown from MSCs will have insulin responsiveness measured
Time Frame: At Birth
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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.
|
At Birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: At 16 weeks and 36 weeks gestation
|
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. |
At 16 weeks and 36 weeks gestation
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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.
Time Frame: at 1 month postnatal visit
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3 of the 6 subtests can be used on 1 month olds. All items scored from 0-2, which include:
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. |
at 1 month postnatal visit
|
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.
Time Frame: at 1 month postnatal visit
|
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 |
at 1 month postnatal visit
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A trained (blinded) researcher will measure body weight on an infant scale
Time Frame: at 1 month postnatal visit
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Body weight will be done to the nearest tenth of a kilogram.
Data will be used to compare body weight measures between groups
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at 1 month postnatal visit
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 12-002524b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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