- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04345757
After Cesarean Time Interval for Exercise (ACTIVE) Trial (ACTIVE)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weill Cornell Medicine - OBGYN
- Phone Number: 212-746-3146
- Email: rbk9001@med.cornell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- New York Presbyterian Hospital Weill Cornell
-
Contact:
- Robin Kalish, MD
- Phone Number: 212-746-3146
- Email: rbk9001@med.cornell.edu
-
Principal Investigator:
- Robin Kalish, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 6, and 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
|
2, 6, and 10 weeks
|
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. |
2, 6, and 10 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robin Kalish, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-11021020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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