Clinical trial NCT05860023: Exercises to Enhance Uterus Involution
Official title: Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterus Involution
Keywords: lactation
pregnancy
pelvic floor
pain
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Uterus involution
timeFrame: Change from baseline uterus involution at one week
measure: Existence and Severity of Pain
timeFrame: Change from baseline pain at one week
Secondary outcomes:
measure: Elapsed time from giving birth to first lactation
timeFrame: First day of the study
measure: Daily Lactation Time
timeFrame: Change from baseline daily lactation time at one week
measure: Daily Lactation Frequency
timeFrame: Change from baseline daily lactation frequency at one week
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University
state: Tuşba
Study officials:
affiliation: Bitlis Eren University
name: Ömer Dursun, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuzuncu Yıl University
name: Burçhan Aydıner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Erhan Dincer, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bitlis Eren University
name: Özal Keleş, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Biruni University
name: Yasemin Aslan Keleş, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.