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

Sponsor
Izmir University of Economics (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05654324
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: pelvic floor muscle exercises
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This research is a prospective and controlled study. The data of the study will be collected from pregnant women (Experimental group) and non-pregnant women (Control group).This research is a prospective and controlled study. The data of the study will be collected from pregnant women (Experimental group) and non-pregnant women (Control group).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Investigation of Acute Effect of Pelvic Floor Muscle Exercises on Inferior Vena Cava
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change of the collapsibility index (%) of IVC [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.

  2. Change of Pulsatility index of IVC [immediately after the intervention]

    Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.

  3. Changes of IVC diameters [immediately after the intervention]

    M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.

Secondary Outcome Measures

  1. Change of the collapsibility index (%) of IVC [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.

  2. Change of Pulsatility index of IVC [5 minutes after the intervention]

    Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.

  3. Changes of IVC diameters [5 minutes after the intervention]

    M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic İzmir Turkey

Sponsors and Collaborators

  • Izmir University of Economics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Seda Yakit Yesilyurt, Lecturer Dr, Izmir University of Economics
ClinicalTrials.gov Identifier:
NCT05654324
Other Study ID Numbers:
  • İEÜ_SYY
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 16, 2022