- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077931
Blood Oxygenation and Exercises in Pregnant Women (exercises)
Blood Oxygenation Response to Aerobic and Breathing Exercises in Pregnant Women
Study Overview
Status
Intervention / Treatment
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]
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt, 12613
- Faculty of Physical Therapy- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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]
|
Walking on treadmill with fixed 0% grade inclination
|
|
Experimental: 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.
|
Walking on treadmill with fixed 0% grade inclination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse oxymeter
Time Frame: 12 weeks.
|
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.
|
12 weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ghada eb elrefaye, professor, Faculty of Physical Therapy, Cairo University, Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CairoU7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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