Influence of Physical Exercise on Endothelial Function in Pregnant Women

NCT00741312 | Completed Phase 1

• 1 other identifier: 182-07
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of regular aerobic exercise on endothelial function in pregnancy.

Conditions

Pregnancy; Preeclampsia; Exercise

Keywords

pregnancy; preeclampsia; exercise

Outcome Measures

Primary Outcomes (1)

• Brachial artery flow-mediated dilation

  Baseline, 8 weeks, 16 weeks

Secondary Outcomes (6)

• high sensitivity C-Reactive Protein

  Baseline, 16 weeks

• Nitrates, Nitrites and cyclic GMP

  Baseline, 16 weeks

• Blood lipid profile

  Baseline, 16 weeks

• Anthropometric indicators

  Baseline, 8 weeks, 16 weeks

• Functional capacity (VO2 Max)

  Baseline, 8 weeks, 16 weeks

Study Arms (2)

I

EXPERIMENTAL

Behavioral: Regular aerobic physical exercise

II

ACTIVE COMPARATOR

Behavioral: Activities of daily living

Interventions

Regular aerobic physical exercise BEHAVIORAL

Walking (10 minutes), aerobic exercise (30 minutes), stretching (10 minutes) and relaxation exercise (10 minutes). Exercise will be performed at three sessions per week. All sessions will be supervised by a physical therapist and a physical educator. The exercise-program follows the ACOG and ACSM exercise prescription. Aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate) measured by the 6-20 Borg's rating scale. Each session starts with a 5 minutes of warm up, followed by 30 minutes of aerobic activity, including 5 minutes cool down. This is followed by 15 minutes of circuit strength training of the upper limbs, lower limbs, and deep abdominal stabilization muscles. The last 5 minutes consists of stretching and relaxation exercises.

I

Activities of daily living BEHAVIORAL

Basic activities of daily living (bathing, dressing, eating, walking) without counseling by a physical therapist.

II

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past four months are eligible for the trial.
• Live foetus at the routine ultrasound scan and a normal pregnancy.
• Gestational age 16 to 20 weeks

You may not qualify if:

• History of high blood pressure
• Chronic medical illnesses (cancer, renal, endocrinologic, psychiatric, neurologic, infectious and cardiovascular diseases)
• Persistent bleeding after week 12 of gestation
• Poorly controlled thyroid disease
• Placenta praevia, incompetent cervix, polyhydramnios, oligohydramnios
• History of miscarriage in the last twelve months
• Diseases that could interfere with participation (following recommendations from ACSM 2000, ACOG 2003).

Sponsors & Collaborators

• Universidad del Valle, Colombia: lead
• Fundación Cardiovascular de Colombia: collaborator

Study Sites (1)

Centro de Salud Cañaveralejo

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (3)

• Pinzon DC, Zamora K, Martinez JH, Florez-Lopez ME, de Plata AC, Mosquera M, Ramirez-Velez R. Type of delivery and gestational age is not affected by pregnant Latin-American women engaging in vigorous exercise: a secondary analysis of data from a controlled randomized trial. Rev Salud Publica (Bogota). 2012 Oct;14(5):731-43.

  PMID: 24652353 DERIVED

• Montoya Arizabaleta AV, Orozco Buitrago L, Aguilar de Plata AC, Mosquera Escudero M, Ramirez-Velez R. Aerobic exercise during pregnancy improves health-related quality of life: a randomised trial. J Physiother. 2010;56(4):253-8. doi: 10.1016/s1836-9553(10)70008-4.

  PMID: 21091415 DERIVED

• Ramirez-Velez R, Aguilar AC, Mosquera M, Garcia RG, Reyes LM, Lopez-Jaramillo P. Clinical trial to assess the effect of physical exercise on endothelial function and insulin resistance in pregnant women. Trials. 2009 Nov 17;10:104. doi: 10.1186/1745-6215-10-104.

  PMID: 19919718 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Motor Activity

Interventions

Activities of Daily Living

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ana C Plata, MSc

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

• Adalberto Sanchez, PhD

  Universidad del Valle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 26, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 21, 2011

Record last verified: 2011-01

Locations

CO (1)