NCT04077931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
Last Updated

September 9, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

August 31, 2019

Last Update Submit

September 5, 2019

Conditions

Keywords

AerobicExercisesBlood OxygenationPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks.

Study Arms (2)

Aerobic exercises

EXPERIMENTAL

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 \[13\]

Other: exercises

Deep breathing exercises

EXPERIMENTAL

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.

Other: exercises

Interventions

Walking on treadmill with fixed 0% grade inclination

Aerobic exercisesDeep breathing exercises

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Participant who had pulmonary diseases
  • cardiovascular diseases
  • psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy- Cairo University

Giza, Dokki, 12613, Egypt

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • ghada eb elrefaye, professor

    Faculty of Physical therapy, Cairo University, Egypt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

August 31, 2019

First Posted

September 4, 2019

Study Start

January 1, 2019

Primary Completion

July 1, 2019

Study Completion

August 1, 2019

Last Updated

September 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women

Shared Documents
STUDY PROTOCOL
Time Frame
3 months
Access Criteria
3 months

Locations