Acute Exercise Effects in Obese Pregnancy

NCT ID: NCT03750695

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2020-03-31

Brief Summary

Obesity before and during pregnancy is associated with a higher risk for a number of obstetric and metabolic complications in women and their offspring. Of particular importance, obese women have a higher risk of developing gestational diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher risk for the development of obesity and diabetes; both largely attributed to higher maternal glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical and have immediate and generational impact. Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal, metabolic and cardiovascular health in non-gravid adolescents and adults with obesity however little is known regarding the effects of exercise during obese pregnancy. This study proposes to collect preliminary data on the independent effects of acute aerobic and resistance rehabilitative exercise on glucose metabolism and vascular function during pregnancy in n=15 obese women in order to inform a large, multisite clinical trial examining the acute and chronic effects of aerobic and resistance exercise on glucose metabolism and vascular function in normal weight, overweight and obese women during pregnancy.

Detailed Description

Maternal obesity prevalence is at a historic high with over 1 in 3 women entering pregnancy obese and 1 in 10 extremely obese. Obesity before and during pregnancy is associated with a higher risk for a number of obstetric and metabolic complications in women and their offspring. Of particular importance, obese women have a higher risk of developing gestational diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher risk for the development of obesity and diabetes; both largely attributed to higher maternal glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical and have immediate and generational impact.

Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal, metabolic and cardiovascular health in non-gravid adolescents and adults with obesity. Observational studies suggest that exercise in pregnancy is safe and higher levels of physical activity before and during pregnancy in normal weight (i.e. lean) women reduces the risk of gestational diabetes and gestational hypertensive disorders; however, little is known regarding the effects of exercise training during obese pregnancy and several important questions still exist. These include: 1) "What are the acute and chronic effects of maternal exercise on glucose metabolism and vascular function?", 2) "Are there different effects of aerobic and resistance type exercise on glucose metabolism and vascular function?" and 3) "What are the physiologic and molecular transducers of maternal aerobic and resistance exercise for changes in maternal glucose metabolism and vascular function during pregnancy?" This pilot project aims to collect preliminary data on these questions.

This proposal would be the first study to collect preliminary data on the independent effects of acute aerobic and resistance rehabilitative exercise in pregnancy, and further, in obese women; a population with a high morbidity during gestation. In addition, this proposal would inform a large, multisite clinical trial examining the acute and chronic effects of aerobic and resistance exercise on glucose metabolism and vascular function in normal weight, overweight and obese women during pregnancy. Moreover, this proposal would provide initial evidence of molecular transducers of acute physical activity/rehabilitative exercise necessary for a large, comprehensive clinical trial examining the molecular transducers of rehabilitative exercise in normal weight, overweight and obese women during different stages of pregnancy.

Specific Aim #1: To characterize the acute effects of aerobic and resistance exercise on glucose metabolism (tolerance, insulin sensitivity and β-cell function) in obese women during mid-pregnancy.

Specific Aim #2: To characterize the acute effects of aerobic and resistance exercise on vascular function in obese women during mid-pregnancy.

Specific Aim #3: To explore the molecular transducers of physiologic responses in glucose metabolism and vascular function following acute aerobic and resistance exercise in obese women during mid-pregnancy.

The hypothesis is that acute aerobic and resistance rehabilitative exercise will improve post-exercise glucose metabolism and vascular function in obese women during mid-pregnancy. In a subsequent multi-site clinical trial, this study will examine differences in physiologic effects and molecular transducers of aerobic and resistance exercise on glucose metabolism and vascular function during different stages of pregnancy in overweight and obese women.

Conditions

Pregnancy Complications; Obesity; Pre-Eclampsia; Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acute Resistance Exercise

One acute exercise session of 40 minutes of resistance exercise

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: BEHAVIORAL

One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise

Acute Aerobic Exercise

One acute session of 40 minutes of aerobic exercise

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)

Acute Resting Session

One session of 40 minutes of quiet rest

Group Type: PLACEBO_COMPARATOR

Rest

Intervention Type: BEHAVIORAL

40 minutes of quiet rest in semi-recumbent position

Interventions

Resistance exercise

One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise

Intervention Type: BEHAVIORAL

Aerobic Exercise

One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)

Intervention Type: BEHAVIORAL

Rest

40 minutes of quiet rest in semi-recumbent position

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. First trimester BMI ≥ 30.0 and <45.0 kg/m2 (calculated from clinical weight and height)

2. Singleton gestation, between 23 weeks and 0/7 days and 28 weeks and 0/7 days

3. Normal fetal anatomy (no major structural abnormalities identified on standard of care survey before enrollment)

4. Established prenatal care at Women's Health Clinic before 18 weeks of gestation, plans to deliver at Barnes-Jewish Hospital

5. Permission from Obstetrics physician provider to participate in study.

Exclusion Criteria

1. Gestational or pre-gestational diabetes diagnosis

2. Inability to provide voluntary consent

3. Currently using illegal drugs (e.g., cocaine, methamphetamine, opiates) (safety risk and potential confounding)

4. Current smoker who does not agree to stop (confounding)

5. Participation in routine (>1x/week) exercise program (may improve glucose metabolism/vascular function)

6. History of heart disease, orthopedic, metabolic or neurological condition that would contraindicate exercise (safety risk)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Cade, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00105627

Identifier Type: -

Identifier Source: org_study_id