After Cesarean Time Interval for Exercise (ACTIVE) Trial (ACTIVE)
Primary Purpose
Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structured exercise
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications focused on measuring Postpartum wellness, Postoperative activity, Postoperative complication, Postpartum complication
Eligibility Criteria
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 due to fetal concerns (anomaly, growth restriction, NICU admission, etc)
Sites / Locations
- New York Presbyterian Hospital Weill CornellRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard instructions
Study Group
Arm Description
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: Structured 10 week exercise protocol
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04345757
First Posted
April 10, 2020
Last Updated
March 23, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT04345757
Brief Title
After Cesarean Time Interval for Exercise (ACTIVE) Trial
Acronym
ACTIVE
Official Title
After Cesarean Time Interval for Exercise (ACTIVE) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Postpartum wellness, Postoperative activity, Postoperative complication, Postpartum complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard instructions
Arm Type
No Intervention
Arm Description
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
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Study group: Structured 10 week exercise protocol
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise
Intervention Description
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 Outcome Measure Information:
Title
Change in wellness
Description
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 Outcome Measure Information:
Title
Change in incidence of post operative complications
Description
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
Title
Change in incidence of depression, anxiety, and decreased physical functioning
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
all pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weill Cornell Medicine - OBGYN
Phone
212-746-3146
Email
rbk9001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Kalish, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Kalish, MD
Phone
212-746-3146
Email
rbk9001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Robin Kalish, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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After Cesarean Time Interval for Exercise (ACTIVE) Trial
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