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Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial

Primary Purpose

Gestational Age, Birth Weight, Anaemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Universidad Politecnica de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Age

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • sedentary (not exercising >20 minutes on >3 days per week)
  • with singleton
  • not at high risk for preterm delivery (no more than one previous preterm deliveries)
  • women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain)

Exclusion Criteria:

  • not being under medical follow-up throughout the entire pregnancy period were not included in the study
  • women having serious medical condition that prevent them from exercising safely

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lifestyle counseling

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2008
    Last Updated
    December 22, 2008
    Sponsor
    Universidad Politecnica de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00813657
    Brief Title
    Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
    Official Title
    Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2000 (undefined)
    Primary Completion Date
    March 2002 (Actual)
    Study Completion Date
    March 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universidad Politecnica de Madrid

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators investigated the effects of a supervised maternal exercise training program (performed during the 2nd and 3rd trimesters of pregnancy) on maternal-newborn unit health outcomes in a group of previously sedentary healthy women. A matched control group was assessed over the same time period. Given the fact that most studies in the field have used aerobic exercises, here the investigators largely focused on very light resistance, toning exercises.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Age, Birth Weight, Anaemia, Gestational Diabetes Mellitus, Type of Delivery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle counseling
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Women in the intervention group were enrolled in three sessions/week of individually supervised, resistance exercise training performed over the second and third trimester of pregnancy (in total 26 weeks, ~80 training sessions). Heart rate (HR) was carefully and individually controlled (≤80% of age-predicted maximum HR value, 220-age) through a heart rate monitor during the training sessions. In brief, each session consisted of 35-40 minutes of exercise divided in a light intensity (≤60% maximal heart rate) warm-up period (~8 minutes), followed by toning and very light resistance exercises (~20 minutes) and a light intensity cool-down (~8 minutes) period. Resistance exercises were performed with barbells (≤3kg per exercise) or low-to-medium resistance bands (Therabands).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: sedentary (not exercising >20 minutes on >3 days per week) with singleton not at high risk for preterm delivery (no more than one previous preterm deliveries) women planning to give birth in the same obstetrics hospital department (Hospital Severo Ochoa, Madrid, Spain) Exclusion Criteria: not being under medical follow-up throughout the entire pregnancy period were not included in the study women having serious medical condition that prevent them from exercising safely

    12. IPD Sharing Statement

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