Pregnancy RelatedSPROUTNCT05394883

The SPROUT (Pilot) Project

A study testing Supervised Exercise and Home Exercise in people with Pregnancy Related and Infant Development, run by State University of New York - Upstate Medical 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

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy Related, Infant Development, Adherence, Treatment
What is being tested?: Supervised Exercise and Home Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2020to 8 Jun 2022
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult pregnant women (i.e. 18 years of age and older)
Low risk, singleton pregnancy
In first trimester of pregnancy (6 to 13 weeks gestation)
Without absolute contraindications to moderate intensity exercise during pregnancy as defined by the American College of Obstetricians and Gynecologists
Exercise clearance from OB/GYN

Who cannot join

Pregnancies greater than low risk for any reason
Pregnant with more than one fetus
Absolute exercise contraindications and/or lack of exercise clearance from OB/GYN

Trial locations and contacts

1 site in 1 country.

United States1 site

SUNY Upstate Medical University
Syracuse, New York, 13210

Other trials in United States

About this study

Official title: The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories

The purpose of this research is to study two different approaches to exercise during pregnancy that investigators believe will result in improved health for moms and babies. The investigators are trying to determine if the two types of exercise programs (supervised \& home exercise) result in health improvements for moms and babies. The investigators also want to see if the tests and questionnaires used in the study can detect changes in a mom's aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months after birth.

Read the detailed description

Historically, pregnant women were advised to refrain from exercise due to concerns of maternal and fetal risk such as preterm delivery, low infant birth rate and fetal stress. Despite current research that has demonstrated substantial benefits for maternal, fetal, and infant health, only 9-15% of pregnant women meet the current physical activity recommendations. In addition, pregnancy exercise research is confounded by a lack of randomized controlled trials (RCT) that include diversity in participant demographics, specifically inner city populations, and difficulty accurately quantifying weekly exercise volume. The investigators propose a pilot RCT investigating two different approaches to exercise intervention across a spectrum of demographics that the investigators believe will result in improved exercise adherence as well as in maternal and infant health outcomes. Specific Aim #1: To determine the feasibility of two types of exercise interventions (supervised \& home exercise) in terms of design, implementation and adherence. Our working hypothesis is that both supervised and home exercise interventions will be implementable as designed in pregnant women as evidenced by recruitment, eligibility, retention, follow-up and exercise adherence from 1st trimester through 6-months post-natal at a 60% rate, but that adherence to the two types of exercise interventions will differ by demographic. A secondary exploratory hypothesis is that the investigators will be able to successfully recruit and retain 50% of our pregnant women from the Syracuse Community Health Center (primarily women with lower resources). Specific Aim #2: To determine the appropriateness of the outcome measures proposed for the exercise intervention in detecting changes in maternal aerobic fitness, quality of life (QOL), fatigue, sleep quality, depression, and weight change throughout pregnancy and 6-months post-natal as measured by the Balke Ware submaximal test; SF-12 Generic Quality of Life (QOL); Multidimensional Fatigue Inventory (MFI); Pittsburgh Sleep Quality Index (PSQLI); Center for Epidemiologic Studies Depression Scale (CES-D); Edinburgh Postnatal Depression Scale (EPDS); and the Pregnancy Physical Activity Questionnaire (PPAQ). Our working hypothesis is that the above outcome measures will be able to detect changes in maternal outcome measures in both exercise groups. Because this is a feasibility study, the results will be used as preliminary data to apply for future funding and also will provide variable quantitative and qualitative data for validating interventions that can increase adherence to exercise guidelines during pregnancy in women with different ethnic and socioeconomic backgrounds.

Conditions: Pregnancy Related, Infant Development, Adherence, Treatment, Activity, Motor
Being tested: Supervised Exercise, Home Exercise
Keywords: pregnancy, supervised exercise, home exercise, fitness, maternal health outcomes, neonatal outcomes, feasibility, adherence
Medical subject headings: Treatment Adherence and Compliance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supervised ExerciseBehavioural
Women randomized to Supervised Exercise group will attend two to three exercise classes/week. Each session will consist of: 5-min flexibility warm-up and cool-down; 40 min of moderate intensity calculated as 40-59% Heart Rate Reserve (HRR) along with Rating of Perceived Exertion (RPE) between 13-14; and 20 minutes of resistance with an additional 30 minutes of unsupervised home aerobic activity per week. The women will be given their choice of aerobic equipment or walking either track/ treadmill to achieve a total of 40 minutes of moderate intensity exercise. The Supervised Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.
Home ExerciseBehavioural
Women assigned to Home Exercise group will receive instructions for their home walking program including tips for walking indoors and outdoors, exercise handouts for warm-up/cool-down activities, demonstrations for resistance training activities and an exercise log. Women assigned to Home Exercise group will be contacted once per week to discuss their progress, barriers/challenges faced, ask questions, and strategies to achieve the exercise guidelines. The Home Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.

Study groups in NCT05394883
Study group	Role	What they receive
Supervised Exercise	Experimental	Women randomized to Supervised Exercise group will attend two to three exercise classes/week. Receives: Behavioral: Supervised Exercise
Home Exercise	Experimental	Women assigned to Home Exercise group will receive instructions for their home walking and exercise program. Receives: Behavioral: Home Exercise
Usual Care	No intervention	The Usual Care group will receive an exercise log to record any weekly activity in addition to a weekly phone call/text/email to remind the individual to complete the weekly exercise log.

What is being measured

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

The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 1 of infant's life
The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 2 of infant's life
The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 3 of infant's life
The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 4 of infant's life
The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 5 of infant's life
The Bayley Scales of Infant Development, 4th edition
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Measured: Month 6 of infant's life
Balke-Ware Submaximal Test
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Measured: Baseline (late first trimester)
Balke-Ware Submaximal Test
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Measured: 3 months post-delivery
Balke-Ware Submaximal Test
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Measured: 6 months post-delivery

Secondary outcomes (8)

Short From-12 Generic Quality of Life
A self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Multidimensional Fatigue Inventory
A 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Higher total scores correspond with more acute levels of fatigue.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pittsburgh Sleep Quality Index
A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Possible range of scores is 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Center for Epidemiologic Studies Depression Scale
A 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Edinburgh Postnatal Depression Scale
Evaluates whether a woman has symptoms of depression and anxiety during pregnancy and in the year following the birth of a child. Possible range of scores is 0 to 30. Mothers scoring above 12 are likely to be suffering from depression.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pregnancy Physical Activity Questionnaire
Self-administered semiquantitative questionnaire for assessing typical physical activity, occupational activity, and home activity completed. From the questionnaire, the number of hours spent in each activity is multiplied by the activity intensity to arrive at a measure of average daily energy expenditure (MET-hours per day) attributable to each activity.
Measured: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Height
Infant height in centimeters
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Weight
Infant weight in kilograms
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life

Timeline

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

4 Oct 20208 Jun 2022

First posted27 May 2022
Study start4 Oct 2020
Primary completion24 May 2022
Study completion8 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (59)Papers the sponsor has linked to this study.
Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: This is a pilot investigation (feasibility) of a future larger study of interventional design with randomization. Participants in the pilot phase of the project will be randomized into one of three groups: supervised exercise, home exercise, or usual care.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05394883
Sponsor's protocol ID: SPROUT
Acronym: SPROUT
Status last verified: Nov 2022
First submitted: 3 May 2022
Last updated: 10 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Because this information is a feasibility study, the investigators will continue to use this study to apply for future grants and it is not possible to determine when this will be complete.

Publications

Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and sedentary behavior among US pregnant women. Prev Med. 2011 Jul-Aug;53(1-2):39-43. doi: 10.1016/j.ypmed.2011.04.014. Epub 2011 May 4.
PubMed 21575654
Jukic A MZ, Evenson KR, Herring AH, Wilcox AJ, Hartmann KE, Daniels JL. Correlates of physical activity at two time points during pregnancy. J Phys Act Health. 2012 Mar;9(3):325-35. doi: 10.1123/jpah.9.3.325.
PubMed 22454434
Santo EC, Forbes PW, Oken E, Belfort MB. Determinants of physical activity frequency and provider advice during pregnancy. BMC Pregnancy Childbirth. 2017 Sep 5;17(1):286. doi: 10.1186/s12884-017-1460-z.
PubMed 28870169
Nascimento SL, Surita FG, Cecatti JG. Physical exercise during pregnancy: a systematic review. Curr Opin Obstet Gynecol. 2012 Dec;24(6):387-94. doi: 10.1097/GCO.0b013e328359f131.
PubMed 23014142
Kramer MS. Aerobic exercise for women during pregnancy. Cochrane Database Syst Rev. 2002;(2):CD000180. doi: 10.1002/14651858.CD000180.
PubMed 12076383
Ramirez-Velez R, Aguilar de Plata AC, Escudero MM, Echeverry I, Ortega JG, Salazar B, Rey JJ, Hormiga C, Lopez-Jaramillo P. Influence of regular aerobic exercise on endothelium-dependent vasodilation and cardiorespiratory fitness in pregnant women. J Obstet Gynaecol Res. 2011 Nov;37(11):1601-8. doi: 10.1111/j.1447-0756.2011.01582.x. Epub 2011 Jul 6.
PubMed 21733037
Hegaard HK, Pedersen BK, Nielsen BB, Damm P. Leisure time physical activity during pregnancy and impact on gestational diabetes mellitus, pre-eclampsia, preterm delivery and birth weight: a review. Acta Obstet Gynecol Scand. 2007;86(11):1290-6. doi: 10.1080/00016340701647341. Epub 2007 Sep 7.
PubMed 17851805
Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD007145. doi: 10.1002/14651858.CD007145.pub3.
PubMed 26068707
Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, Ramirez-Velez R. Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. J Physiother. 2012;58(1):9-15. doi: 10.1016/S1836-9553(12)70067-X.
PubMed 22341377
Baker JH, Rothenberger SD, Kline CE, Okun ML. Exercise during early pregnancy is associated with greater sleep continuity. Behav Sleep Med. 2018 Sep-Oct;16(5):482-493. doi: 10.1080/15402002.2016.1228649. Epub 2016 Oct 14.
PubMed 27739877
Krzepota J, Sadowska D, Biernat E. Relationships between Physical Activity and Quality of Life in Pregnant Women in the Second and Third Trimester. Int J Environ Res Public Health. 2018 Dec 5;15(12):2745. doi: 10.3390/ijerph15122745.
PubMed 30563083
Kolomanska-Bogucka D, Mazur-Bialy AI. Physical Activity and the Occurrence of Postnatal Depression-A Systematic Review. Medicina (Kaunas). 2019 Sep 2;55(9):560. doi: 10.3390/medicina55090560.
PubMed 31480778
Wiebe HW, Boule NG, Chari R, Davenport MH. The effect of supervised prenatal exercise on fetal growth: a meta-analysis. Obstet Gynecol. 2015 May;125(5):1185-1194. doi: 10.1097/AOG.0000000000000801.
PubMed 25932847
McMillan AG, May LE, Gaines GG, Isler C, Kuehn D. Effects of Aerobic Exercise during Pregnancy on 1-Month Infant Neuromotor Skills. Med Sci Sports Exerc. 2019 Aug;51(8):1671-1676. doi: 10.1249/MSS.0000000000001958.
PubMed 30817721
Davenport MH, McCurdy AP, Mottola MF, Skow RJ, Meah VL, Poitras VJ, Jaramillo Garcia A, Gray CE, Barrowman N, Riske L, Sobierajski F, James M, Nagpal T, Marchand AA, Nuspl M, Slater LG, Barakat R, Adamo KB, Davies GA, Ruchat SM. Impact of prenatal exercise on both prenatal and postnatal anxiety and depressive symptoms: a systematic review and meta-analysis. Br J Sports Med. 2018 Nov;52(21):1376-1385. doi: 10.1136/bjsports-2018-099697.
PubMed 30337464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The SPROUT (Pilot) Project: Starting Pregnancy With Robustness for Optimal Upward Trajectories
ClinicalTrials.gov ID: NCT05394883
Acronym / sponsor ID: SPROUT / SPROUT
Conditions: Pregnancy Related, Infant Development, Adherence, Treatment, Activity, Motor
Keywords: pregnancy, supervised exercise, home exercise, fitness, maternal health outcomes, neonatal outcomes, feasibility, adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: State University of New York - Upstate Medical UniversityUniversity, hospital or other
Study start: 4 Oct 2020 (actual)
Primary completion: 24 May 2022 (actual)
Study completion: 8 Jun 2022 (actual)
First posted: 27 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: This is a pilot investigation (feasibility) of a future larger study of interventional design with randomization. Participants in the pilot phase of the project will be randomized into one of three groups: supervised exercise, home exercise, or usual care.

Arm	Type	Receives
Supervised Exercise	Experimental	Behavioral: Supervised ExerciseWomen randomized to Supervised Exercise group will attend two to three exercise classes/week.
Home Exercise	Experimental	Behavioral: Home ExerciseWomen assigned to Home Exercise group will receive instructions for their home walking and exercise program.
Usual Care	No intervention	–The Usual Care group will receive an exercise log to record any weekly activity in addition to a weekly phone call/text/email to remind the individual to complete the weekly exercise log.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult pregnant women (i.e. 18 years of age and older)
Low risk, singleton pregnancy
In first trimester of pregnancy (6 to 13 weeks gestation)
Without absolute contraindications to moderate intensity exercise during pregnancy as defined by the American College of Obstetricians and Gynecologists
Exercise clearance from OB/GYN

Key exclusion criteria (3 listed)

Pregnancies greater than low risk for any reason
Pregnant with more than one fetus
Absolute exercise contraindications and/or lack of exercise clearance from OB/GYN

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Supervised ExerciseWomen randomized to Supervised Exercise group will attend two to three exercise classes/week. Each session will consist of: 5-min flexibility warm-up and cool-down; 40 min of moderate intensity calculated as 40-59% Heart Rate Reserve (HRR) along with Rating of Perceived Exertion (RPE) between 13-14; and 20 minutes of resistance with an additional 30 minutes of unsupervised home aerobic activity per week. The women will be given their choice of aerobic equipment or walking either track/ treadmill to achieve a total of 40 minutes of moderate intensity exercise. The Supervised Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.	Behavioural	Supervised Exercise
Home ExerciseWomen assigned to Home Exercise group will receive instructions for their home walking program including tips for walking indoors and outdoors, exercise handouts for warm-up/cool-down activities, demonstrations for resistance training activities and an exercise log. Women assigned to Home Exercise group will be contacted once per week to discuss their progress, barriers/challenges faced, ask questions, and strategies to achieve the exercise guidelines. The Home Exercise group will receive exercise counseling during their first meeting in addition to materials on the benefits of exercise, a log to record additional activity completed each week, goal setting, making time for exercise/making exercise a habit and exercise behavioral strategies.	Behavioural	Home Exercise

Primary outcome

The Bayley Scales of Infant Development, 4th edition
Time frame: Month 1 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
The Bayley Scales of Infant Development, 4th edition
Time frame: Month 2 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
The Bayley Scales of Infant Development, 4th edition
Time frame: Month 3 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
The Bayley Scales of Infant Development, 4th edition
Time frame: Month 4 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
The Bayley Scales of Infant Development, 4th edition
Time frame: Month 5 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
The Bayley Scales of Infant Development, 4th edition
Time frame: Month 6 of infant's life
The Bayley-4 is a standardized, norm-referenced tool with subtest level scaled scores, domain level composite scores, percentile ranks, and developmental age equivalents. The investigators will utilize the cognitive and motor sections only for this study. The purpose of this outcome measure is to compare developmental trajectories over the first six months of life between the three groups (supervised exercise group, home exercise group, and control group). The highest possible score on a subtest or subdomain is 19, and the lowest possible score is 1. Scores from 8-12 are considered average.
Balke-Ware Submaximal Test
Time frame: Baseline (late first trimester)
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Balke-Ware Submaximal Test
Time frame: 3 months post-delivery
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.
Balke-Ware Submaximal Test
Time frame: 6 months post-delivery
Used to estimate cardiovascular condition and endurance by measuring maximum oxygen uptake, known as VO2max. Comparison of the participant's heart rate and blood pressure response to exercise between measurements will assess the effect of the intervention on the participant's aerobic capacity. A reduction in heart rate or blood pressure may be consistent with improved aerobic conditioning.

8 secondary outcomes

Short From-12 Generic Quality of Life
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Multidimensional Fatigue Inventory
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pittsburgh Sleep Quality Index
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Center for Epidemiologic Studies Depression Scale
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Edinburgh Postnatal Depression Scale
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Pregnancy Physical Activity Questionnaire
Time frame: Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal
Height
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life
Weight
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
Background: PubMed 21575654Evenson KR, Wen F. Prevalence and correlates of objectively measured physical activity and sedentary behavior among US pregnant women. Prev Med. 2011 Jul-Aug;53(1-2):39-43. doi: 10.1016/j.ypmed.2011.04.014. Epub 2011 May 4.
Background: PubMed 22454434Jukic A MZ, Evenson KR, Herring AH, Wilcox AJ, Hartmann KE, Daniels JL. Correlates of physical activity at two time points during pregnancy. J Phys Act Health. 2012 Mar;9(3):325-35. doi: 10.1123/jpah.9.3.325.
Background: PubMed 28870169Santo EC, Forbes PW, Oken E, Belfort MB. Determinants of physical activity frequency and provider advice during pregnancy. BMC Pregnancy Childbirth. 2017 Sep 5;17(1):286. doi: 10.1186/s12884-017-1460-z.
Background: PubMed 23014142Nascimento SL, Surita FG, Cecatti JG. Physical exercise during pregnancy: a systematic review. Curr Opin Obstet Gynecol. 2012 Dec;24(6):387-94. doi: 10.1097/GCO.0b013e328359f131.
Background: PubMed 12076383Kramer MS. Aerobic exercise for women during pregnancy. Cochrane Database Syst Rev. 2002;(2):CD000180. doi: 10.1002/14651858.CD000180.
Background: PubMed 21733037Ramirez-Velez R, Aguilar de Plata AC, Escudero MM, Echeverry I, Ortega JG, Salazar B, Rey JJ, Hormiga C, Lopez-Jaramillo P. Influence of regular aerobic exercise on endothelium-dependent vasodilation and cardiorespiratory fitness in pregnant women. J Obstet Gynaecol Res. 2011 Nov;37(11):1601-8. doi: 10.1111/j.1447-0756.2011.01582.x. Epub 2011 Jul 6.
Background: PubMed 17851805Hegaard HK, Pedersen BK, Nielsen BB, Damm P. Leisure time physical activity during pregnancy and impact on gestational diabetes mellitus, pre-eclampsia, preterm delivery and birth weight: a review. Acta Obstet Gynecol Scand. 2007;86(11):1290-6. doi: 10.1080/00016340701647341. Epub 2007 Sep 7.
Background: PubMed 26068707Muktabhant B, Lawrie TA, Lumbiganon P, Laopaiboon M. Diet or exercise, or both, for preventing excessive weight gain in pregnancy. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD007145. doi: 10.1002/14651858.CD007145.pub3.
Background: PubMed 22341377Robledo-Colonia AF, Sandoval-Restrepo N, Mosquera-Valderrama YF, Escobar-Hurtado C, Ramirez-Velez R. Aerobic exercise training during pregnancy reduces depressive symptoms in nulliparous women: a randomised trial. J Physiother. 2012;58(1):9-15. doi: 10.1016/S1836-9553(12)70067-X.
Background: PubMed 27739877Baker JH, Rothenberger SD, Kline CE, Okun ML. Exercise during early pregnancy is associated with greater sleep continuity. Behav Sleep Med. 2018 Sep-Oct;16(5):482-493. doi: 10.1080/15402002.2016.1228649. Epub 2016 Oct 14.
Background: PubMed 30563083Krzepota J, Sadowska D, Biernat E. Relationships between Physical Activity and Quality of Life in Pregnant Women in the Second and Third Trimester. Int J Environ Res Public Health. 2018 Dec 5;15(12):2745. doi: 10.3390/ijerph15122745.
Background: PubMed 31480778Kolomanska-Bogucka D, Mazur-Bialy AI. Physical Activity and the Occurrence of Postnatal Depression-A Systematic Review. Medicina (Kaunas). 2019 Sep 2;55(9):560. doi: 10.3390/medicina55090560.
Individual participant dataSharing planned: No. Because this information is a feasibility study, the investigators will continue to use this study to apply for future grants and it is not possible to determine when this will be complete.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erin Wentz, PT, PhD principal investigator

State University of New York - Upstate Medical University

Carol Sames, PhD principal investigator

State University of New York - Upstate Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 10 Nov 2022. 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?

The Bayley Scales of Infant Development, 4th edition (time frame: Month 1 of infant's life). The study lists 9 primary outcomes in all. 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 NCT05394883, which also lists 59 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 10 Nov 2022; AzTrials last refreshed its copy on 28 Oct 2026.