Exercises to Enhance Uterus Involution

Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uterus Involution
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ömer dursun, Asst. Prof.; Phone Number: +90 5426088687; Email: fztomrdrsn@gmail.com
• Study Contact Backup: Name: Erhan Dincer, M.Sc.; Phone Number: +90 5442543857; Email: fzterhan@hotmail.com

Study Locations

• Turkey
  • Tuşba
    • Van, Tuşba, Turkey, 65080
      • Van Yuzuncu Yıl University
      • Contact: Burçhan Aydıner, M.D.; Phone Number: +90 553 600 74 24; Email: burchanaydıner@hotmail.com
      • Contact: Özal Keleş, Ph.D.; Phone Number: +90 553 960 22 52; Email: okeles@beu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In this group, mothers will only take routine gynecologic. No additional treatment will be applied to the mothers in this group.
Experimental: Aerobic Exercise 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.	Other: Exercise; Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.
Experimental: Pelvic Floor Muscle Strengthening Group; 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.	Other: Exercise; Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline uterus involution at one week
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.	Change from baseline pain at one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elapsed time from giving birth to first lactation	Elapsed time will be recorded in minutes from giving birth to first lactation	First day of the study
Daily Lactation Time	Daily lactation time and frequency will be calculated based on the mothers' reports.	Change from baseline daily lactation time at one week
Daily Lactation Frequency	Daily lactation frequency will be calculated based on the mothers' reports.	Change from baseline daily lactation frequency at one week

Collaborators and Investigators

• Sponsor: Bitlis Eren University
• Investigators: Principal Investigator: ömer dursun, Asst. Prof., Bitlis Eren University; Principal Investigator: Burçhan Aydıner, M.D., Yuzuncu Yıl University; Principal Investigator: Erhan Dincer, M.Sc., Bitlis Eren University; Principal Investigator: Özal Keleş, Ph.D., Bitlis Eren University; Principal Investigator: Yasemin Aslan Keleş, M.Sc., Biruni University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Pelvic Floor Muscle Strengthening Exercises

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2023
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): October 15, 2023

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain; pregnancy; lactation; pelvic floor
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Uterine Diseases
• Other Study ID Numbers: BEUFTR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No