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

N/A
Recruiting
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

ACTIVE Trial 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.Check my eligibility
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.See study design
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.

ACTIVE Trial 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.

ACTIVE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in wellness
Secondary outcome measures
Anxiety
Change in incidence of post operative complications

ACTIVE 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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,315,695 Total Patients Enrolled
1 Trials studying Postoperative Complications
200 Patients Enrolled for Postoperative Complications
Hospital for Special Surgery, New YorkOTHER
243 Previous Clinical Trials
58,730 Total Patients Enrolled
Robin Kalish, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Structured exercise Clinical Trial Eligibility Overview. Trial Name: NCT04345757 — N/A
Postoperative Complications Research Study Groups: Standard instructions, Study Group
Postoperative Complications Clinical Trial 2023: Structured exercise Highlights & Side Effects. Trial Name: NCT04345757 — N/A
Structured exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04345757 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participants in this research?

"Affirmative. Information available on clinicaltrials.gov suggests that this experiment is presently gathering patients, which commenced recruitment on November 1st 2020 and was last updated March 28th 2022. 600 individuals will be required from a single site for the study to move forward."

Answered by AI

Is this experimental protocol open to participants at present?

"Clinicaltrials.gov currently indicates that this medical trial is actively recruiting. It was created on November 1st 2020 and edited most recently on March 28th 2022."

Answered by AI
~14 spots leftby Jun 2024