Uterus InvolutionNCT05860023
Exercises to Enhance Uterus Involution
A study testing Exercise in people with Uterus Involution, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterus Involution
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Eclampsia
- Puerperal psychosis
- Severe preeclampsia
- Multiple pregnancy story
- Uterus abnormality story
- Uterus surgery story
Show all 10Show fewer
- Use of artificial estrogen
- Existence of systemic, mental or pregnancy related diseases
- Occurrence of complication during or after the pregnancy
- Symptoms of uterus subinvolution
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl University
Van, Tuşba, 65080
Burçhan Aydıner, M.D., 553 600 74 24 ext. +90, burchanaydıner@hotmail.com
Özal Keleş, Ph.D., 553 960 22 52 ext. +90, okeles@beu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Uterus Involution
- Being tested
- Exercise
- Keywords
- lactation, pregnancy, pelvic floor, pain
- Medical subject headings
- Breast Feeding, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline pain at one week
Secondary outcomes (3)
Elapsed time from giving birth to first lactation
Elapsed time will be recorded in minutes from giving birth to first lactation
Measured: First day of the study
Daily Lactation Time
Daily lactation time and frequency will be calculated based on the mothers' reports.
Measured: Change from baseline daily lactation time at one week
Daily Lactation Frequency
Daily lactation frequency will be calculated based on the mothers' reports.
Measured: Change from baseline daily lactation frequency at one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterus InvolutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Dursun, Bitlis Eren University
- Investigators
- Ömer Dursun, Asst. Prof., Principal investigator, Bitlis Eren UniversityBurçhan Aydıner, M.D., Principal investigator, Yuzuncu Yil UniversityErhan Dincer, M.Sc., Principal investigator, Bitlis Eren UniversityÖzal Keleş, Ph.D., Principal investigator, Bitlis Eren UniversityYasemin Aslan Keleş, M.Sc., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860023
- Sponsor's protocol ID
- BEUFTR-1
- Status last verified
- May 2023
- First submitted
- 17 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28371959Emshoff 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.
PubMed 21726939Tanaka 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.
PubMed 11153730Snyder 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.
PubMed 34548116
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution
- ClinicalTrials.gov ID
- NCT05860023
- Acronym / sponsor ID
- BEUFTR-1
- Conditions
- Uterus Involution
- Keywords
- lactation, pregnancy, pelvic floor, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: ExerciseThis 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. |
| Pelvic Floor Muscle Strengthening Group | Experimental | Other: ExerciseThis 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. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Eclampsia
- Puerperal psychosis
- Severe preeclampsia
- Multiple pregnancy story
- Uterus abnormality story
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseIndividuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises. | Other | Aerobic Exercise Group, Pelvic Floor Muscle Strengthening Group |
Primary outcome
Uterus involution
Time frame: 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.
Existence and Severity of Pain
Time frame: 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.
3 secondary outcomes
Elapsed time from giving birth to first lactation
Time frame: First day of the study
Daily Lactation Time
Time frame: Change from baseline daily lactation time at one week
Daily Lactation Frequency
Time frame: Change from baseline daily lactation frequency at one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Background: PubMed 28371959Kristoschek 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.
- Background: PubMed 21726939Emshoff 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.
- Background: PubMed 11153730Tanaka 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.
- Background: PubMed 34548116Snyder 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.
- Pelvic Floor Muscle Strengthening ExercisesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ömer Dursun, Asst. Prof. principal investigator
Bitlis Eren University
Burçhan Aydıner, M.D. principal investigator
Yuzuncu Yil University
Erhan Dincer, M.Sc. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Uterus Involution, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ömer dursun, Asst. Prof. (5426088687 ext. +90, fztomrdrsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterus involution (time frame: Change from baseline uterus involution at one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05860023, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.