After Cesarean Time Interval for Exercise (ACTIVE) Trial

Postoperative Complications Clinical Trial

— ACTIVE  

Official title:

After Cesarean Time Interval for Exercise (ACTIVE) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04345757
• Other study ID #: 19-11021020
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Weill Medical College of Cornell University
• Contact: Weill Cornell Medicine - OBGYN
• Phone: 212-746-3146
• Email: rbk9001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Behavioral:
• Structured 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital Weill Cornell	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2, 6, and 10 weeks
Secondary	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	2, 6, and 10 weeks
Secondary	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.	2, 6, and 10 weeks