After Cesarean Time Interval for Exercise (ACTIVE) Trial

NCT04345757 | Completed DMC

• 1 other identifier: 19-11021020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications

Keywords

Postpartum wellness; Postoperative activity; Postoperative complication; Postpartum complication

Outcome Measures

Primary Outcomes (1)

• Change in wellness

  As measured by scores in the completion of the PROMIS GSF assessment. The PROMIS GSF assessment uses a method of scoring requiring responses to each item for each participant. Each question usually has five response options ranging in value from one to five. All questions must be answered in order to produce a valid score using the scoring tables. A score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function-Mobility, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.

  2, 6, and 10 weeks

Secondary Outcomes (2)

• Change in incidence of post operative complications

  2, 6, and 10 weeks

• Change in incidence of depression, anxiety, and decreased physical functioning

  2, 6, and 10 weeks

Study Arms (2)

Standard instructions

NO 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

Study Group

EXPERIMENTAL

Study group: Structured 10 week exercise protocol

Behavioral: Structured exercise

Interventions

Structured exercise BEHAVIORAL

The exercise program will be designed by a physical therapist (Ms. Patricia Ladis) who specializes in postnatal rehabilitation and will be supervised by sports medicine physicians from the Hospital For Special Surgery (HSS). The structured program will include approximately 10 minutes of core muscle group exercises. They will begin this program 2 weeks after their cesarean section. The study group will perform these exercises 5 times per week.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: all pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Hospital for Special Surgery, New York: collaborator

Study Sites (1)

New York Presbyterian Hospital Weill Cornell

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robin Kalish, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: November 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)