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CompletedNCT04345757ACTIVEUpdated Feb 27, 2026

After Cesarean Time Interval for Exercise (ACTIVE) Trial

An interventional study of Structured exercise in Postoperative Complications, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
02

Conditions studied

  • Postoperative Complications

Keywords

  • Postpartum wellness
  • Postoperative activity
  • Postoperative complication
  • Postpartum complication
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 200 is above the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • No intervention
    Standard instructions

    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

  • Experimental
    Study Group

    Study group: Structured 10 week exercise protocol

    Behavioral: Structured exercise

Interventions

  • BehavioralStructured exercise

    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.

06

What researchers measure

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.

    Time frame: 2, 6, and 10 weeks

Secondary outcomes

  1. Change in incidence of post operative complications

    As measured by number of subjects presenting with any of the following: * Wound separation, dehiscence, hernia etc. * Re-hospitalization for wound concerns * Infection * Increased pain, abdominal/core muscle injury * Less breastmilk production (adequate-inadequate, Likert scale 1-5) * Urinary incontinence * Improved fitness

    Time frame: 2, 6, and 10 weeks

  2. Change in incidence of depression, anxiety, and decreased physical functioning

    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.

    Time frame: 2, 6, and 10 weeks

07

Study locations

1 site
  • New York Presbyterian Hospital Weill Cornell
    New York, New York 10021, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04345757
Lead sponsor
Weill Medical College of Cornell University
Collaborators
Hospital for Special Surgery, New York
Responsible party
Sponsor
First posted
Apr 14, 2020
Start date
Nov 1, 2020
Primary completion
Sep 1, 2025
Completion
Sep 1, 2025
Last update
Feb 27, 2026

Study contacts

Robin Kalish, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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