Aerobic and Breathing Exercises in Pregnant WomenexercisesNCT04077931
Blood Oxygenation and Exercises in Pregnant Women
A study testing exercises in people with Aerobic and Breathing Exercises in Pregnant Women, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aerobic and Breathing Exercises in Pregnant Women
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- their ages were ranged from 25 to 30 years
- body mass index (BMI) were less than 30 kg/m2
Who cannot join
- Participant who had pulmonary diseases
- cardiovascular diseases
- psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Oxygenation Response to Aerobic and Breathing Exercises in Pregnant Women
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.
Read the 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]
- Being tested
- exercises
- Keywords
- Aerobic, Exercises, Blood Oxygenation, Pregnancy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
Walking on treadmill with fixed 0% grade inclination
| Study group | Role | What they receive |
|---|---|---|
| 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] Receives: 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. Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic and Breathing Exercises in Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Hany Farid Eid Morsy Elsisi, yasser anees
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada eb elrefaye, professor, Principal investigator, Faculty of Physical therapy, Cairo University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077931
- Sponsor's protocol ID
- CairoU7
- Acronym
- exercises
- Status last verified
- Jan 2019
- First submitted
- 31 Aug 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Oxygenation Response to Aerobic and Breathing Exercises in Pregnant Women
- ClinicalTrials.gov ID
- NCT04077931
- Acronym / sponsor ID
- exercises / CairoU7
- Keywords
- Aerobic, Exercises, Blood Oxygenation, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Hany Farid Eid Morsy Elsisi, yasser anees
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercises | Experimental | Other: exercisesShe 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] |
| Deep breathing exercises | Experimental | Other: exercisesTechnique 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. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- their ages were ranged from 25 to 30 years
- body mass index (BMI) were less than 30 kg/m2
Key exclusion criteria (3 listed)
- Participant who had pulmonary diseases
- cardiovascular diseases
- psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisesWalking on treadmill with fixed 0% grade inclination | Other | Aerobic exercises, Deep breathing exercises |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: Yes. investigate the blood oxygenation response to aerobic and breathing exercises in pregnant women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ghada eb elrefaye, professor principal investigator
Faculty of Physical therapy, Cairo University, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Aerobic and Breathing Exercises in Pregnant Women, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse oxymeter (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.