Blood Oxygenation and Exercises in Pregnant Women

NCT ID: NCT04077931

Last Updated: 2019-09-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-08-01

Brief Summary

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To investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women. Participants and methods: A total of forty pregnant women participated in the study who were at the beginning of 3rd trimester. Their ages ranged from 25 to 30 years and their body mass index (BMI) was less than 30 kg/m2. They were assigned into two groups (A) performed aerobic exercises in a form of walking for 20-30 min. on treadmill at 60-75% of the target heart rate (THR) of each women, 3 times per week in addition to deep breathing exercises in form of diaphragmatic and lateral costal breathing, group (B) who performed deep breathing exercises only in form of diaphragmatic and lateral costal breathing. The program continued for 3 months, 3 times per week. The oxygen saturation (SaO2) was measured twice time firstly, at the beginning of 3rd trimester of pregnancy then after 3 months that at 24, 36 gestation weeks.

Detailed Description

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Forty volunteers pregnant women at the beginning of 3rd trimester participated in this study. They were selected randomly from the gynecological outpatient clinic, at Kasr El Eini Universal Hospital, their ages were ranged from 25 to 30 years and body mass index indices (BMI) were less than 30 kg/m2. All participants were pregnant woman at the beginning of the 3rd trimester 12 weeks. Exclusion criteria of the study were as follows: Participant who had pulmonary diseases, cardiovascular diseases and psychiatric disorders.

Participants were assigned randomly used sealed envelope into two groups (A\&B) equally in number. Group (A): Consisted of twenty pregnant woman at the beginning of the 3rd trimester. They performed aerobic exercise training in the form of walking on treadmill for 20 min, 3 times per week for 12 weeks. Then performed deep breathing exercises in form of diaphragmatic and lateral costal breathing. Group (B): Consisted of twenty pregnant woman at the beginning of the 3rd trimester who performed deep breathing exercises only in form of diaphragmatic and lateral costal breathing.

Methods Before the start of the first session, each pregnant woman was informed about program of exercises and informed consent form was signed from each woman before participation in the study. This study was conducted at from January 2018 to September 2019.

1-Aerobic exercises for all participants in group A: Women performed aerobic exercises in a form of walking for 20 min on treadmill 3 times per week for 12 weeks.

Treadmill: (power 220-V., 50/60 Hz): its speed, inclination and timer are adjustable and it also provided with control plane to display the exercises parameters

Intensity of exercises: The intensity of exercises was calculated as 60-75% of her target heart rate (THR) \[11\] (Q'Sullivan and Schmitz, 1999) as follow:

THR= {60-75% (HR max - HR rest)} + HR rest.

Where:

HR rest: resting heart rate in beat minute. MRH (Maximum heart rate=220 - Age in years) \[12\]

Conditions

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Aerobic and Breathing Exercises in Pregnant Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women. Participants and methods: A total of forty pregnant women participated in the study who were at the beginning of 3rd trimester. Their ages ranged from 25 to 30 years and their body mass index (BMI) was less than 30 kg/m2. They were assigned into two groups (A) performed aerobic exercises in a form of walking for 20-30 min. on treadmill at 60-75% of the target heart rate (THR) of each women, 3 times per week in addition to deep breathing exercises in form of diaphragmatic and lateral costal breathing, group (B) who performed deep breathing exercises only in form of diaphragmatic and lateral costal breathing. The program continued for 3 months, 3 times per week. The oxygen saturation (SaO2) was measured twice time firstly, at the beginning of 3rd trimester of pregnancy then after 3 months that at 24, 36 gestation weeks.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The women were randomly assigned to the treatment group(A) (n=25) or the control group (B) (n=25) by an independent person who selected numbers from sealed envelopes that containing numbers chosen by a random number generator.

Study Groups

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Aerobic exercises

She asked to start walking with the speed of the machine was adjusted at 0.8 km/hour, so her resting pulse rate increases, then we increased the speed by 0.2 km/hour gradually every 2 minute (to give a time for adjustment of heart rate) till reaching our target heart rate (not less than 60% and not more than 75% of target heart rate). So the intensity of exercises can be increase or decrease only by changing the speed of treadmill according to target heart rate \[13\]

Group Type EXPERIMENTAL

exercises

Intervention Type OTHER

Walking on treadmill with fixed 0% grade inclination

Deep breathing exercises

Technique of breathing exercises: Regular aerobic exercises in a form breathing exercises included duration of 30 min. at 40-70% VO2 max. performed 2-3 per week. Each woman practiced deep breathing exercises 30 min. in the of form (diaphragmatic breathing exercises, 15 min. and lateral costal breathing exercises 15 min.) 3 times per week for 12 weeks.

Group Type EXPERIMENTAL

exercises

Intervention Type OTHER

Walking on treadmill with fixed 0% grade inclination

Interventions

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exercises

Walking on treadmill with fixed 0% grade inclination

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* their ages were ranged from 25 to 30 years
* body mass index (BMI) were less than 30 kg/m2

Exclusion Criteria

* Participant who had pulmonary diseases
* cardiovascular diseases
* psychiatric disorders
Minimum Eligible Age

25 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hany Farid Eid Morsy Elsisi

UNKNOWN

Sponsor Role collaborator

yasser anees

UNKNOWN

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Ebrahim El Refaye

assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical therapy, Cairo University, Egypt.

Locations

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Faculty of physical therapy- Cairo University

Giza, Dokki, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CairoU7

Identifier Type: -

Identifier Source: org_study_id

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