Exercises to Enhance Uterus Involution

NCT05860023 | Unknown

• 1 other identifier: BEUFTR-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterus Involution

Keywords

lactation; pregnancy; pelvic floor; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Elapsed time from giving birth to first lactation

  First day of the study

• Daily Lactation Time

  Change from baseline daily lactation time at one week

• Daily Lactation Frequency

  Change from baseline daily lactation frequency at one week

Study Arms (3)

Control Group

NO INTERVENTION

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

Aerobic Exercise Group

EXPERIMENTAL

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

Pelvic Floor Muscle Strengthening Group

EXPERIMENTAL

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

Interventions

Exercise OTHER

Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.

Aerobic Exercise Group; Pelvic Floor Muscle Strengthening Group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Gender Eligibility Details: Mothers who gave birth to their first children will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65080, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28371959 BACKGROUND

• 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.

  PMID: 21726939 BACKGROUND

• 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.

  PMID: 11153730 BACKGROUND

• 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.

  PMID: 34548116 BACKGROUND

Related Links

• Pelvic Floor Muscle Strengthening Exercises

MeSH Terms

Conditions

Breast Feeding; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ömer Dursun, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Burçhan Aydıner, M.D.

  Yuzuncu Yil 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ömer dursun, Asst. Prof.

CONTACT

5426088687; fztomrdrsn@gmail.com

erhan dincer, M.Sc.

CONTACT

5442543857; fzterhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Interventions and assessment will be performed by separate researchers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 16, 2023
• Study Start: June 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: October 15, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)