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Blood Oxygenation and Exercises in Pregnant Women (exercises)

Primary Purpose

Aerobic and Breathing Exercises in Pregnant Women

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aerobic and Breathing Exercises in Pregnant Women focused on measuring Aerobic, Exercises, Blood Oxygenation, Pregnancy

Eligibility Criteria

25 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of physical therapy- Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aerobic exercises

Deep breathing exercises

Arm Description

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]

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.

Outcomes

Primary Outcome Measures

Pulse oxymeter
It was used to measure oxygen saturation (SaO2) on the right index of each individual. Each individual sit quietly for about 5 minutes before the measurement and sit silently during the measurement.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2019
Last Updated
September 5, 2019
Sponsor
Cairo University
Collaborators
Hany Farid Eid Morsy Elsisi, yasser anees
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1. Study Identification

Unique Protocol Identification Number
NCT04077931
Brief Title
Blood Oxygenation and Exercises in Pregnant Women
Acronym
exercises
Official Title
Blood Oxygenation Response to Aerobic and Breathing Exercises in Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Hany Farid Eid Morsy Elsisi, yasser anees

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aerobic and Breathing Exercises in Pregnant Women
Keywords
Aerobic, Exercises, Blood Oxygenation, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercises
Arm Type
Experimental
Arm Description
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]
Arm Title
Deep breathing exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
Walking on treadmill with fixed 0% grade inclination
Primary Outcome Measure Information:
Title
Pulse oxymeter
Description
It was used to measure oxygen saturation (SaO2) on the right index of each individual. Each individual sit quietly for about 5 minutes before the measurement and sit silently during the measurement.
Time Frame
12 weeks.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ghada eb elrefaye, professor
Organizational Affiliation
Faculty of Physical therapy, Cairo University, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of physical therapy- Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women
IPD Sharing Time Frame
3 months
IPD Sharing Access Criteria
3 months

Learn more about this trial

Blood Oxygenation and Exercises in Pregnant Women

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