After Cesarean Time Interval for Exercise (ACTIVE) Trial

Weill Cornell Medicine (WCM)

Status: Active, not recruiting

Conditions: Postoperative Complications

Treatments: Behavioral: Structured exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04345757

19-11021020

Details and patient eligibility

About

The purpose of this study is to test whether or not activity restrictions after a cesarean section are warranted and if exercise can improve postpartum wellness. This research study is being done because there is no science-based evidence to support postpartum activity restrictions after cesarean sections.

Participants will be randomly placed into one of the following study groups:

• Standard postpartum and post-operative instructions group: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit
• Study group: Structured 10 week exercise protocol consisting of core strengthening exercises (concentrating on the abdominal, gluteal, and pelvic areas), breathing exercises, and diaphragm exercises.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pregnant woman at least 18 years of age
• carrying only one baby at time of delivery
• delivery planned by scheduled cesarean section
• baby of gestational age of > 37 weeks
• no known restrictions to exercise.

Exclusion criteria

• woman with pre-existing post operative complications
• medical history with exercise limitations/disabilities
• carrying more than one baby at time of delivery
• delivery (planned by scheduled or emergent) cesarean section with fetal concerns (anomaly, growth restriction, NICU admission, etc)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard instructions

No Intervention group

Description:

Standard instructions: activity restrictions, including no strenuous exercise, sexual intercourse, or lifting objects greater than 25 pounds for 6 weeks or until evaluation at the 6 week postpartum visit

Study Group

Experimental group

Description:

Study group: Structured 10 week exercise protocol

Treatment:

Behavioral: Structured exercise