Exercises to Enhance Uterus Involution

• Sponsor: Bitlis Eren University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05860023
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 11.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterus Involution	Other: Exercise	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Single (Outcomes Assessor)
• Masking Description: Interventions and assessment will be performed by separate researchers.
• Primary Purpose: Treatment
• Official Title: Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution
• Anticipated Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Sep 15, 2023
• Anticipated Study Completion Date: Oct 15, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Uterus involution [Change from baseline uterus involution at one week]

   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.

2. Existence and Severity of Pain [Change from baseline pain at one week]

   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

1. Elapsed time from giving birth to first lactation [First day of the study]

   Elapsed time will be recorded in minutes from giving birth to first lactation

2. Daily Lactation Time [Change from baseline daily lactation time at one week]

   Daily lactation time and frequency will be calculated based on the mothers' reports.

3. Daily Lactation Frequency [Change from baseline daily lactation frequency at one week]

   Daily lactation frequency will be calculated based on the mothers' reports.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yüzüncü Yıl University	Van	Tuşba	Turkey	65080

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pelvic Floor Muscle Strengthening Exercises

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Omer Dursun, Asst. Prof., Bitlis Eren University
• ClinicalTrials.gov Identifier: NCT05860023
• Other Study ID Numbers: BEUFTR-1
• First Posted: May 16, 2023
• Last Update Posted: May 16, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Omer Dursun, Asst. Prof., Bitlis Eren University: lactation; pregnancy; pelvic floor; pain
• Additional relevant MeSH terms: Uterine Diseases; Chronic Disease

Study Results

No Results Posted as of May 16, 2023