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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00813657
Other study ID # 01562
Secondary ID 01562
Status Completed
Phase Phase 4
First received December 22, 2008
Last updated December 22, 2008
Start date January 2000
Est. completion date March 2002

Study information

Verified date December 2008
Source Universidad Politecnica de Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 2002
Est. primary completion date March 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Primary Purpose: Prevention


Intervention

Behavioral:
Exercise
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).

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Politecnica de Madrid
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