ClinicalTrials.Veeva

Menu

The SPROUT (Pilot) Project

S

State University of New York - Upstate Medical University

Status

Completed

Conditions

Adherence, Treatment
Pregnancy Related
Activity, Motor
Infant Development

Treatments

Behavioral: Supervised Exercise
Behavioral: Home Exercise

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 3 patient groups

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

Trial documents
2

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems