- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00813657
Resistance Exercise Training During Pregnancy: a Randomized Controlled Trial
December 22, 2008 updated by: Universidad Politecnica de Madrid
Effects of Resistance Exercise Training Program Performed During the 2nd and 3rd Trimesters of Pregnancy on Maternal and Newborn Health
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle counseling
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Primary Completion (Actual)
March 1, 2002
Study Completion (Actual)
March 1, 2002
Study Registration Dates
First Submitted
December 22, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (Estimate)
December 23, 2008
Study Record Updates
Last Update Posted (Estimate)
December 23, 2008
Last Update Submitted That Met QC Criteria
December 22, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01562
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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