Exercises to Enhance Uterus Involution

Study Overview
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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.

Official Title
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Effect of Pelvic Floor Muscle Strengthening and Aerobic Exercises on Uterus Involution

Conditions
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Uterus Involution

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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<br>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<br>* Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.<br>|
| Experimental: Pelvic Floor Muscle Strengthening Group<br>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<br>* Individuals in the experimental group will be asked to perform aerobic exercise or pelvic floor muscle strengthening exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elapsed time from giving birth to first lactation | Elapsed time will be recorded in minutes from giving birth to first lactation | First day of the study | 
| Daily Lactation Time | Daily lactation time and frequency will be calculated based on the mothers' reports. | Change from baseline daily lactation time at one week | 
| Daily Lactation Frequency | Daily lactation frequency will be calculated based on the mothers' reports. | Change from baseline daily lactation frequency at one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactation, pregnancy, pelvic floor, pain