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Completed

NCT Number: NCT04345757

After Cesarean Time Interval for Exercise (ACTIVE) 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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital Weill Cornell

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Change in wellness

    Time frame: 2, 6, and 10 weeks

    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.

Secondary outcomes

  1. Change in incidence of post operative complications

    Time frame: 2, 6, and 10 weeks

    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

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

    Time frame: 2, 6, and 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Hospital for Special Surgery, New York

Registry information

Acronym: ACTIVE

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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