Structured Exercise for Postoperative Recovery After Cesarean Section

(ACTIVE Trial)

Overseen By Weill Cornell Medicine - OBGYN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Post operative complications, Exercise limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Structured exercise for postoperative recovery after cesarean section?

Research shows that physiotherapy, which includes structured exercise, can help reduce pain and improve functional activities after a cesarean delivery. Additionally, using digital step counters to encourage movement has been shown to improve mobility in high-risk patients after a cesarean section. ^{1 2 3 4 5}

Is structured exercise safe for humans after a cesarean section?

Research shows that structured exercise, like a return to running program, can be safely implemented after a cesarean section, leading to functional improvements without reported safety issues. ^{1 6 7 8 9}

How does structured exercise differ from other treatments for recovery after a cesarean section?

Structured exercise is unique because it focuses on a planned and progressive physical activity routine to aid recovery after a cesarean section, unlike standard care which may not emphasize exercise. This approach can improve mobility and functional activities, as seen in similar programs like return-to-running and physiotherapy, which have shown benefits in postpartum recovery. ^{1 5 6 10 11}

What is the purpose of this trial?

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.

Research Team

Robin Kalish, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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.

Inclusion Criteria

You do not have any physical limitations that prevent you from exercising.

Carrying only one baby at time of delivery

My baby was born after 37 weeks of pregnancy.

Exclusion Criteria

Delivery (planned by scheduled or emergent) cesarean section with fetal concerns (anomaly, growth restriction, NICU admission, etc)

I have physical limitations that restrict my ability to exercise.

You are pregnant with more than one baby.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either standard postpartum instructions with activity restrictions or a structured 10-week exercise protocol

10 weeks

3 visits (in-person) at 2, 6, and 10 weeks

Follow-up

Participants are monitored for changes in wellness, depression, anxiety, and physical functioning after treatment

4 weeks

Treatment Details

Interventions

• Structured exercise

Trial Overview 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.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

Study group: Structured 10 week exercise protocol

Group II: Standard instructions Active Control 1 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

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Hospital for Special Surgery, New York

Collaborator

Trials

257

Recruited

61,800+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Examination of the association of physical activity during pregnancy after cesarean delivery and vaginal birth among Chinese women. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Enhanced recovery after cesarean from the patient perspective: a prospective study of the ERAC Questionnaire (ERAC-Q). [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early aggressive exercise for postoperative rehabilitation after discectomy. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Effects of physiotherapy on pain and functional activities after cesarean delivery. [2012]

6. England pubmed.ncbi.nlm.nih.gov

A return to running program for the postpartum client: a case report. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

How does the ERAS protocol work in patients who underwent cesarean section? (HERMES study). [2023]

8. England pubmed.ncbi.nlm.nih.gov

Influence of prenatal exercise on the relationship between maternal overweight and obesity and select delivery outcomes. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The relationship between incidence of cesarean section and physical activity during pregnancy among pregnant women of diverse age groups: Dose-response meta-analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Exercise prescription for overweight and obese women: pregnancy and postpartum. [2009]