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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether structured exercise benefits women after a cesarean section. It seeks to determine if exercise improves recovery and overall wellness compared to traditional activity restrictions, such as avoiding heavy lifting or strenuous exercise. Participants will join one of two groups: one following standard post-surgery instructions and the other participating in a 10-week exercise program focused on core, breathing, and diaphragm exercises. Women who are pregnant, planning a cesarean delivery, carrying one baby, and have no exercise restrictions may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance post-cesarean recovery practices.

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 prior data suggests that this exercise protocol is safe for postpartum recovery?

Research has shown that planned exercise after surgery is safe and beneficial. One study found that post-surgery exercise can prevent issues like stiffness or pain from inactivity. Another study discovered that a specific exercise plan after a C-section helped new mothers recover faster and experience less pain. Reviews also support the inclusion of exercise programs in recovery plans, aiding quicker rehabilitation. These findings suggest that planned exercise is generally well-tolerated and positively impacts recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the structured exercise protocol for postpartum recovery after a cesarean section because it offers a proactive approach to healing, unlike the traditional method of mostly resting with activity restrictions. This exercise regimen could potentially speed up recovery, improve physical fitness, and enhance overall well-being during the postpartum period. By integrating a structured 10-week exercise plan, the study aims to empower new mothers with a safe way to regain strength and energy, which could redefine the standard postpartum recovery process.

What evidence suggests that structured exercise is effective for postpartum recovery after a cesarean section?

Research has shown that planned exercise after a cesarean section can aid recovery. In this trial, participants in the study group will follow a structured 10-week exercise protocol. One study found that exercises focusing on strengthening core muscles can reduce issues from insufficient movement after surgery. Another study demonstrated that learning physiotherapy exercises before a cesarean section can lead to better recovery outcomes. Early movement and gradually increasing exercise have also proven beneficial. Overall, these findings suggest that a structured exercise program might enhance recovery for women after a cesarean section. ^{1 6 7 8 9}

Who Is on the Research Team?

Robin Kalish, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. journals.lww.com journals.lww.com/ijcn/fulltext/2019/20020/effect_of_structured_exercise_sessions_on.12.aspx

Effect of Structured Exercise Sessions on Post-operative... The study concluded that structured post-operative exercise sessions are effective in reducing the potential post-operative problems associated with immobility ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8812015/

Effectiveness of face-to-face physiotherapy training and ... Face-to-face physiotherapy training and education prior to elective CS appears to be a promising intervention to improve the post-operative outcomes.

3. innovationaljournals.com innovationaljournals.com/index.php/ijnr/article/view/255

To Assess the Effect of Early Ambulation and Progressive ... Conclusion: Above data show that early ambulation and progressive exercises among experimental group were effective and improve postoperative ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X23002819

Review Article Outcomes and outcome measures utilised ... In this scoping review, we primarily aimed to identify outcomes reported in effectiveness studies of interventions for postoperative CD pain.

5. ejhc.journals.ekb.eg ejhc.journals.ekb.eg/article_407463_9b3733f425141fcf1c6d89c611a2b1cd.pdf

Effect of Post-natal Exercises Bundle Sessions on Mothers' ... Conclusion: The result was concluded that implementation of post-natal exercises bundle sessions had a positive effect on improving mothers' recovery after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244618/

Maternal Outcomes Following Emergency Cesarean Delivery The ERAS protocol significantly improves maternal outcomes following emergency CD, including faster recovery, reduced pain, and improved ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00211-6/fulltext

Evidence-based surgical procedures to optimize ... Implementing evidence-based procedures for caesarean sections can improve safety maternal and perinatal outcomes, and optimise the use of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325008753

Postoperative physiotherapy in enhanced recovery pathways This review supports the feasibility and potential benefits of a structured physiotherapy interventions within enhanced recovery protocols.

9. becarispublishing.com becarispublishing.com/doi/10.2217/cer-2021-0258

Early mobilization in enhanced recovery after surgery ... Early mobilization reduces the risk of postoperative complications, accelerates the recovery of functional walking capacity, positively impacts ...