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
About this trial
This is an interventional prevention trial for Gestational Age
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
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
NCT ID
NCT00813657
First Posted
December 22, 2008
Last Updated
December 22, 2008
Sponsor
Universidad Politecnica de Madrid
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
Learn more about this trial
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
We'll reach out to this number within 24 hrs