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Structured Exercise for Postoperative Recovery After Cesarean Section (ACTIVE Trial)

N/A

Waitlist Available

Led By Robin Kalish, MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baby of gestational age of > 37 weeks

Pregnant woman at least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2, 6, and 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not activity restrictions are necessary after a cesarean section, and if exercise can help with postpartum wellness.

Who is the study for?

This trial is for women over 18 who are planning a scheduled cesarean section at >37 weeks with one baby and no known exercise restrictions. It's not for those with pre-existing postoperative complications, exercise limitations/disabilities, fetal concerns requiring NICU admission, or multiple pregnancies.

What is being tested?

The ACTIVE Trial is testing if activity after a cesarean can be beneficial. Women will either follow standard post-op care with activity restrictions or engage in a structured 10-week exercise program focusing on core strength and breathing exercises.

What are the potential side effects?

Since the intervention involves structured exercise, potential side effects may include typical post-exercise symptoms such as muscle soreness or fatigue. However, specific risks related to exercising after cesarean delivery will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born after 37 weeks of pregnancy.

Select...

I am a pregnant woman and I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 6, and 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 6, and 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 6, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in wellness

Secondary study objectives

Anxiety

Change in incidence of post operative complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study GroupExperimental Treatment1 Intervention

Study group: Structured 10 week exercise protocol

Group II: Standard instructionsActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Structured exercise

2019

N/A

~230

0 / 2Eligibility criteria met