The SPROUT (Pilot) Project

NCT05394883 | Completed

• 1 other identifier: SPROUT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Related; Infant Development; Adherence, Treatment; Activity, Motor

Keywords

pregnancy; supervised exercise; home exercise; fitness; maternal health outcomes; neonatal outcomes; feasibility; adherence

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 months post-delivery

Secondary Outcomes (8)

• Short From-12 Generic Quality of Life

  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

  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

  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

  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

  Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal

Study Arms (3)

Supervised Exercise

EXPERIMENTAL

Women randomized to Supervised Exercise group will attend two to three exercise classes/week.

Behavioral: Supervised Exercise

Home Exercise

EXPERIMENTAL

Women assigned to Home Exercise group will receive instructions for their home walking and exercise program.

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.

Interventions

Supervised Exercise BEHAVIORAL

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.

Supervised Exercise

Home Exercise BEHAVIORAL

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.

Home Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (59)

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Related Links

• Census bureau statistics for Syracuse

MeSH Terms

Conditions

Treatment Adherence and Compliance; Motor Activity

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Erin Wentz, PT, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

• Carol Sames, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 27, 2022
• Study Start: October 4, 2020
• Primary Completion: May 24, 2022
• Study Completion: June 8, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)