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Exercises to Enhance Uterus Involution

Primary Purpose

Uterus Involution

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Sponsored by
Bitlis Eren University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterus Involution focused on measuring lactation, pregnancy, pelvic floor, pain

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Age of 19 to 35 years New born APGAR score is equal or higher than 8 First pregnancy Giving birth in 37th to 40th weeks of the pregnancy Birthweight ranging from 2500 g to 4000 g Exclusion Criteria: Eclampsia Puerperal psychosis Severe preeclampsia Multiple pregnancy story Uterus abnormality story Uterus surgery story Use of artificial estrogen Existence of systemic, mental or pregnancy related diseases Occurrence of complication during or after the pregnancy Symptoms of uterus subinvolution

Sites / Locations

  • Van Yüzüncü Yıl University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Aerobic Exercise Group

Pelvic Floor Muscle Strengthening Group

Arm Description

In this group, mothers will only take routine gynecologic. No additional treatment will be applied to the mothers in this group.

This group will attend to seven days aerobic exercise program with 65% to 75% of their maximum heart rate monitored with pulse oximeter. Aerobic exercise will take 30 minutes consisting of 5 minute warm up, 20 minute jogging and 5 minute cool down. Prior to discharge pulse oximeter will be given to the participants for self monitorization. Their compliance to exercise will be questioned with daily phone calls.

This group will attend to seven days pelvic floor muscle strengthening programme with moderate intensity consisting of 6 exercises recommended by the national association for incontinence. Prior to discharge exercise sheets will be given to the participants. Their compliance to exercise will be questioned with daily phone calls.

Outcomes

Primary Outcome Measures

Uterus involution
To assess the uterus involution uterus volume, uterus diameters and thickness will be measured with ultrasound imaging. Ultrasound imaging will be performed in dorsal lithotomy position, without uterus activation, and with minimal uterus fullness. Uterus volume calculation will be performed with this formula: uterus anteroposterior diameter x uterus transverse diameter x uterus longitudinal diameter x 0.45.
Existence and Severity of Pain
Pain will be assessed with visual analog scale (VAS). VAS consists of 10 cm horizontal line. At the one edge of the line 0 point is located meaning no pain, at the other edge 10 point is located meaning worst pain. Mothers will be asked to mark the point matching to their perceived pain. Minimal clinical significance of VAS is reported to be 1.1 or 1.2 cm. VAS and ultrasound imaging will be performed in first, second and eighth days of the study.

Secondary Outcome Measures

Elapsed time from giving birth to first lactation
Elapsed time will be recorded in minutes from giving birth to first lactation
Daily Lactation Time
Daily lactation time and frequency will be calculated based on the mothers' reports.
Daily Lactation Frequency
Daily lactation frequency will be calculated based on the mothers' reports.

Full Information

First Posted
April 17, 2023
Last Updated
May 7, 2023
Sponsor
Bitlis Eren University
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1. Study Identification

Unique Protocol Identification Number
NCT05860023
Brief Title
Exercises to Enhance Uterus Involution
Official Title
Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized controlled study was to compare the effect of aerobic exercise and pelvic floor muscle strengthening exercises on uterus involution. In the scope of study following questions will be answered at the end of the study. First which of the exercise type is more effective to enhance uterus involution? Secondly, does exercises induce changes in lactation rate during the study period? Thirdly, does exercises improve the experienced pain? Study will be consisted of three groups as control group, pelvic floor exercise group and aerobic exercise group. Control group will take routine gynaecological treatment. Pelvic floor muscle strengthening exercise group will attend to seven day pelvic floor strengthening exercise programme. Aerobic exercise group will attend to seven day aerobic exercise programme consisting of walking.
Detailed Description
A total of 45 mothers who satisfies the eligibility criteria of the study will be recruited to the study. Following to the recruitment process mothers will be randomly assigned to the one of the three groups. Mothers in the control group will only take routine gynecologic treatment. Mothers in the aerobic exercise group will attend to aerobic exercises starting from the second day of the hospitalization for one week. Mothers who will be in pelvic floor strengthening exercise group after the randomization will be asked to perform six exercises with moderate difficulty that are recommended by the national association for incontinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterus Involution
Keywords
lactation, pregnancy, pelvic floor, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group will take routine gynecologic treatment. Aerobic exercise group will attend to aerobic exercise programme for seven days. Aerobic exercise will be given with an intensity of 65% to 75% of the maximum heart rate of the individuals monitored by pulse oximeter.Aerobic exercise will take 30 minutes consisting of 5 minutes warm up, 20 minutes jogging, and 5 minutes cool down. Pelvic floor muscle strengthening group will be asked to perform six pelvic floor muscle strengthening exercise with moderate difficulty, recommended by the national association for incontinence for seven days. These exercises are straight leg raise, oblique reaches, partial curl up-obliques, pelvic tilt with crunch, quadruped hip extension, and bridge with adduction. Prior to discharge exercise sheet will be given to participants to do the exercises at home. Participants will be called daily to question their compliance to the exercise. Participants will be asked to keep exercise diary as well.
Masking
Outcomes Assessor
Masking Description
Interventions and assessment will be performed by separate researchers.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In this group, mothers will only take routine gynecologic. No additional treatment will be applied to the mothers in this group.
Arm Title
Aerobic Exercise Group
Arm Type
Experimental
Arm Description
This group will attend to seven days aerobic exercise program with 65% to 75% of their maximum heart rate monitored with pulse oximeter. Aerobic exercise will take 30 minutes consisting of 5 minute warm up, 20 minute jogging and 5 minute cool down. Prior to discharge pulse oximeter will be given to the participants for self monitorization. Their compliance to exercise will be questioned with daily phone calls.
Arm Title
Pelvic Floor Muscle Strengthening Group
Arm Type
Experimental
Arm Description
This group will attend to seven days pelvic floor muscle strengthening programme with moderate intensity consisting of 6 exercises recommended by the national association for incontinence. Prior to discharge exercise sheets will be given to the participants. Their compliance to exercise will be questioned with daily phone calls.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.
Primary Outcome Measure Information:
Title
Uterus involution
Description
To assess the uterus involution uterus volume, uterus diameters and thickness will be measured with ultrasound imaging. Ultrasound imaging will be performed in dorsal lithotomy position, without uterus activation, and with minimal uterus fullness. Uterus volume calculation will be performed with this formula: uterus anteroposterior diameter x uterus transverse diameter x uterus longitudinal diameter x 0.45.
Time Frame
Change from baseline uterus involution at one week
Title
Existence and Severity of Pain
Description
Pain will be assessed with visual analog scale (VAS). VAS consists of 10 cm horizontal line. At the one edge of the line 0 point is located meaning no pain, at the other edge 10 point is located meaning worst pain. Mothers will be asked to mark the point matching to their perceived pain. Minimal clinical significance of VAS is reported to be 1.1 or 1.2 cm. VAS and ultrasound imaging will be performed in first, second and eighth days of the study.
Time Frame
Change from baseline pain at one week
Secondary Outcome Measure Information:
Title
Elapsed time from giving birth to first lactation
Description
Elapsed time will be recorded in minutes from giving birth to first lactation
Time Frame
First day of the study
Title
Daily Lactation Time
Description
Daily lactation time and frequency will be calculated based on the mothers' reports.
Time Frame
Change from baseline daily lactation time at one week
Title
Daily Lactation Frequency
Description
Daily lactation frequency will be calculated based on the mothers' reports.
Time Frame
Change from baseline daily lactation frequency at one week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers who gave birth to their first children will be recruited.
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age of 19 to 35 years New born APGAR score is equal or higher than 8 First pregnancy Giving birth in 37th to 40th weeks of the pregnancy Birthweight ranging from 2500 g to 4000 g Exclusion Criteria: Eclampsia Puerperal psychosis Severe preeclampsia Multiple pregnancy story Uterus abnormality story Uterus surgery story Use of artificial estrogen Existence of systemic, mental or pregnancy related diseases Occurrence of complication during or after the pregnancy Symptoms of uterus subinvolution
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ömer dursun, Asst. Prof.
Phone
5426088687
Ext
+90
Email
fztomrdrsn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
erhan dincer, M.Sc.
Phone
5442543857
Ext
+90
Email
fzterhan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Dursun, Asst. Prof.
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burçhan Aydıner, M.D.
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erhan Dincer, M.Sc.
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özal Keleş, Ph.D.
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasemin Aslan Keleş, M.Sc.
Organizational Affiliation
Biruni University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yüzüncü Yıl University
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burçhan Aydıner, M.D.
Phone
553 600 74 24
Ext
+90
Email
burchanaydıner@hotmail.com
First Name & Middle Initial & Last Name & Degree
Özal Keleş, Ph.D.
Phone
553 960 22 52
Ext
+90
Email
okeles@beu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28371959
Citation
Kristoschek JH, Moreira de Sa RA, Silva FCD, Vellarde GC. Ultrasonographic Evaluation of Uterine Involution in the Early Puerperium. Rev Bras Ginecol Obstet. 2017 Apr;39(4):149-154. doi: 10.1055/s-0037-1601418. Epub 2017 Apr 3.
Results Reference
background
PubMed Identifier
21726939
Citation
Emshoff R, Bertram S, Emshoff I. Clinically important difference thresholds of the visual analog scale: a conceptual model for identifying meaningful intraindividual changes for pain intensity. Pain. 2011 Oct;152(10):2277-2282. doi: 10.1016/j.pain.2011.06.003. Epub 2011 Jul 2.
Results Reference
background
PubMed Identifier
11153730
Citation
Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.
Results Reference
background
PubMed Identifier
34548116
Citation
Snyder AR, Greif SM, Clugston JR, FitzGerald DB, Yarrow JF, Babikian T, Giza CC, Thompson FJ, Bauer RM. The Effect of Aerobic Exercise on Concussion Recovery: A Pilot Clinical Trial. J Int Neuropsychol Soc. 2021 Sep;27(8):790-804. doi: 10.1017/S1355617721000886.
Results Reference
background
Links:
URL
https://nafc.org/downloadable-pelvic-floor-exercises/
Description
Pelvic Floor Muscle Strengthening Exercises

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Exercises to Enhance Uterus Involution

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