Postoperative ComplicationsACTIVENCT04345757
After Cesarean Time Interval for Exercise (ACTIVE) Trial
A study testing Structured exercise in people with Postoperative Complications, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Structured exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital Weill Cornell
New York, New York, 10021
About this study
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
- Being tested
- Structured exercise
- Keywords
- Postpartum wellness, Postoperative activity, Postoperative complication, Postpartum complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exerciseBehavioural
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 | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Structured exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 6, and 10 weeks
Secondary outcomes (2)
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
Measured: 2, 6, and 10 weeks
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.
Measured: 2, 6, and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Nov 2020
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Sponsor
- Investigators
- Robin Kalish, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345757
- Sponsor's protocol ID
- 19-11021020
- Acronym
- ACTIVE
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Cesarean Time Interval for Exercise (ACTIVE) Trial
- ClinicalTrials.gov ID
- NCT04345757
- Acronym / sponsor ID
- ACTIVE / 19-11021020
- Conditions
- Postoperative Complications
- Keywords
- Postpartum wellness, Postoperative activity, Postoperative complication, Postpartum complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Structured exerciseStudy group: Structured 10 week exercise protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured exerciseThe 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. | Behavioural | Study Group |
Primary outcome
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.
2 secondary outcomes
Change in incidence of post operative complications
Time frame: 2, 6, and 10 weeks
Change in incidence of depression, anxiety, and decreased physical functioning
Time frame: 2, 6, and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Kalish, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise in people with Postoperative Complications, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in wellness (time frame: 2, 6, and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.