Exercises to Enhance Uterus Involution

NCT ID: NCT05860023

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2023-10-15

Brief Summary

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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

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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.

Conditions

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Uterus Involution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Interventions and assessment will be performed by separate researchers.

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Interventions

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Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Omer Dursun

Asst. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ömer Dursun, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Burçhan Aydıner, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Erhan Dincer, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Özal Keleş, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Yasemin Aslan Keleş, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

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Van Yüzüncü Yıl University

Van, Tuşba, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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ömer dursun, Asst. Prof.

Role: CONTACT

5426088687 ext. +90

erhan dincer, M.Sc.

Role: CONTACT

5442543857 ext. +90

Facility Contacts

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Burçhan Aydıner, M.D.

Role: primary

553 600 74 24 ext. +90

Özal Keleş, Ph.D.

Role: backup

553 960 22 52 ext. +90

References

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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.

Reference Type BACKGROUND
PMID: 28371959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21726939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11153730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34548116 (View on PubMed)

Related Links

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https://nafc.org/downloadable-pelvic-floor-exercises/

Pelvic Floor Muscle Strengthening Exercises

Other Identifiers

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BEUFTR-1

Identifier Type: -

Identifier Source: org_study_id

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