The SPROUT (Pilot) Project

Sponsor

State University of New York - Upstate Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05394883

Collaborator

(none)

Enrollment

Location

Arms

20.1

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Infant Development Adherence, Treatment Activity, Motor	Behavioral: Supervised Exercise Behavioral: Home Exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 4, 2020

Anticipated Primary Completion Date :

May 24, 2022

Anticipated Study Completion Date :

Jun 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supervised Exercise Women randomized to Supervised Exercise group will attend two to three exercise classes/week.	Behavioral: Supervised Exercise 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.
Experimental: Home Exercise Women assigned to Home Exercise group will receive instructions for their home walking and exercise program.	Behavioral: Home Exercise 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.
No Intervention: Usual Care 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.

Arm

Intervention/Treatment

Experimental: Supervised Exercise

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

Behavioral: Supervised Exercise

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.

Experimental: Home Exercise

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

Behavioral: Home Exercise

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.

No Intervention: Usual Care

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.

Outcome Measures

Primary Outcome Measures

The Bayley Scales of Infant Development, 4th edition [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 [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 [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 [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 [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 [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 [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 [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 [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.

Secondary Outcome Measures

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]
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.
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]
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.
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]
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.
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]
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.
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]
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.
Pregnancy Physical Activity Questionnaire [Baseline (late first trimester), late second trimester (25-26 weeks), late third trimester (37-38 weeks), and monthly through 6-months post-natal]
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.
Height [Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life]
Infant height in centimeters
Weight [Month 1, Month 2, Month 3, Month 4, Month 5, Month 6 of infant's life]
Infant weight in kilograms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY Upstate Medical University	Syracuse	New York	United States	13210

Sponsors and Collaborators

State University of New York - Upstate Medical University

Investigators

Principal Investigator: 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