The Effect of Pelvic Floor Muscle Exercises on the Inferior Vena Cava

November 1, 2023 updated by: Seda Yakit Yesilyurt, Izmir University of Economics

Investigation of Acute Effect of Pelvic Floor Muscle Exercises on Inferior Vena Cava

The aim of this study is to examine the effect of pelvic floor muscle exercises on the hemodynamic responses of the vena cava inferior in pregnant and non-pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The IVC is responsible for approximately two-thirds of the total venous return to the heart. The blood flow in the IVC is affected by the respiratory and cardiac cycle. One of the factors affecting blood flow is pregnancy. Studies have shown that the hemodynamic responses of the IVC may vary depending on the position, and that the supine position puts pressure on the IVC during pregnancy.

Compression of the growing fetus against the IVC can cause supine hypotensive syndrome and fetal danger. However, there is no definite finding about the effects of exercise performed in the supine position. Jefferys et al. reported that the reduction in blood flow at rest is twice that that occurs during exercise and that the level of blood flow should not be a cause for concern in healthy asymptomatic women who choose to exercise in the supine position in late pregnancy. Based on this information, we predict that pelvic floor muscle exercises can change the hemodynamic responses of the IVC and reduce the compression on it.

In order to evaluate the effect of pelvic floor muscle exercises on hemodynamic responses of IVC and compression on it, pregnant and non-pregnant women will be measured by ultrasonography. Women eligible for the study will be seated and rested for 30 minutes before taking the measurement. Then, he will be taken to the supine position, rested for 2 minutes, and the first measurements will be taken at the 3rd minute. pelvic floor muscle exercises will be applied for 5 minutes as stated in the literature. Ultrasonographic measurements will be repeated in the supine position immediately after the pelvic floor exercises and 5 minutes after the exercise. Measurements will be applied to all participants in the same order. During the exercises blood pressure, heart rate and peripheral oxygen saturation will be monitored. Before and after the exercises, the heart rate and blood pressure parameters of the women will be recorded.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Experimental group

  • Being pregnant between the ages of 18-40,
  • At least primary school graduate and able to read and write,
  • The gestational age is 20-40 weeks,
  • Not having any mental problems that prevent cooperation and understanding.

Control group

  • Being a non-pregnant woman who is in the same age range as the experimental group,
  • At least primary school graduate and able to read and write,
  • Not having any mental problems that prevent cooperation and understanding.

Exclusion Criteria:

  • Pregnant women with acute or chronic diseases with poor placental adaptation and vascular damage such as diabetes, chronic arterial hypertension and preeclampsia, as the fetus is closer to the threshold of hypoxia and acidemia and adaptive phenomena may fail,
  • Pregnant women with intra-uterine growth restriction and fetal anomaly,
  • Pregnant women with cardiovascular disease,
  • Pregnant women considered as high risk by the obstetrician,
  • Pregnant women with premature, premature birth or miscarriage risk,
  • Pregnant women diagnosed with neurological disease,
  • Obese women (body mass index > 30),
  • Women whose IVC measurements cannot be made with ultrasonography,
  • Women with severe low back pain (not able to do housework regularly),
  • Women who have been diagnosed with a psychiatric illness,
  • Women with a history of gynecological surgery,
  • Women with pelvic floor dysfunction,
  • Women who cannot lie in the supine position.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pregnant women
Pregnant women aged 18-40, 20-40 weeks of gestation.
Other: pelvic floor muscle exercises
Before the pelvic floor exercises are taught to all women participating in the study, a brief informational training about the function and structure of the pelvic floor and pelvis will be given using visuals. The application protocol will be given by experienced specialist physiotherapists who have received special training on pelvic floor muscle training. In this study, the training protocol described by Mørkved et al and Bø et al will be used. An exercise series will consist of slow and fast muscle contractions of the pelvic floor muscles. The exercise series will include 10 reps of maximum pelvic floor muscle contraction held for 6 seconds followed by three rapid muscle contractions. A 10-second rest period will be given between each exercise series. A total of 5 minutes, 4 repetitions of pelvic floor muscle contraction series will be applied, including the rest period.
Active Comparator: Non-Pregnant
Being a non-pregnant woman who is in the same age range as the experimental group.
Other: pelvic floor muscle exercises
Before the pelvic floor exercises are taught to all women participating in the study, a brief informational training about the function and structure of the pelvic floor and pelvis will be given using visuals. The application protocol will be given by experienced specialist physiotherapists who have received special training on pelvic floor muscle training. In this study, the training protocol described by Mørkved et al and Bø et al will be used. An exercise series will consist of slow and fast muscle contractions of the pelvic floor muscles. The exercise series will include 10 reps of maximum pelvic floor muscle contraction held for 6 seconds followed by three rapid muscle contractions. A 10-second rest period will be given between each exercise series. A total of 5 minutes, 4 repetitions of pelvic floor muscle contraction series will be applied, including the rest period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the collapsibility index (%) of IVC
Time Frame: immediately after the intervention

The collapsibility index (%) of IVC will be calculated using the formula:

[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter] × 100.
immediately after the intervention
Change of Pulsatility index of IVC
Time Frame: immediately after the intervention
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
immediately after the intervention
Changes of IVC diameters
Time Frame: immediately after the intervention
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the collapsibility index (%) of IVC
Time Frame: 5 minutes after the intervention

The collapsibility index (%) of IVC will be calculated using the formula:

[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter] × 100.
5 minutes after the intervention
Change of Pulsatility index of IVC
Time Frame: 5 minutes after the intervention
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
5 minutes after the intervention
Changes of IVC diameters
Time Frame: 5 minutes after the intervention
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
5 minutes after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir University of Economics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • İEÜ_SYY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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