Hypertension ,PregnancyNCT04352374
Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension
A study testing Aerobic exercise and Device guided breathing in people with Hypertension ,Pregnancy, run by Cairo University at 1 site in Egypt.
Trial summary
Aim To compare between the effect of aerobic exercise versus device guided breathing (DGB) on blood pressure in gestational hypertensive patients. Participants and Methods Randomized controlled trial, which included 60 singleton pregnant women (at 21-week gestation) diagnosed with gestational hypertension. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension ,Pregnancy
- What is being tested?
- Aerobic exercise and Device guided breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Apr 2020
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty singleton pregnant women, diagnosed with gestational hypertension (GH) at 21- week of gestation, and aged between 25-35 years were randomized. GH was defined as blood pressure higher than 140/90 measured on two separate occasions, more than 6 hours apart, without the presence of protein in the urine and diagnosed after 20 weeks of gestation.
Who cannot join
- Women with multiple pregnancies, cervical insufficiency, vaginal bleeding, heart disease, systemic lupus erythematosus, kidney failure, and neurologic disorders were excluded from the study. For inclusion in the study, pregnant women also could not be engaged in any supervised physical exercise, at the time of selection and when signing a free written informed consent term.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Aerobic Exercises Versus Device Guided Breathing on Gestational Hypertension
Aim To compare between the effect of aerobic exercise versus device guided breathing (DGB) on blood pressure in gestational hypertensive patients. Participants and Methods Randomized controlled trial, which included 60 singleton pregnant women (at 21-week gestation) diagnosed with gestational hypertension. They were divided into two groups: group (A) received aerobic exercise with a treadmill twice a week, for 45 minutes; and group (B) received Device guided breathing exercise for at least 40 min per week, with each session lasting at least 10 min. Assessment of the systolic blood pressure (SBP) and diastolic blood pressure (DBP) for all participants in the two studied groups (A, B) was carried out at begining of the study and at week-36 of gestation with mercury column sphygmomanometer.
Read the detailed description
Sixty singleton pregnant women, diagnosed with gestational hypertension (GH) at 21- week of gestation, and aged between 25-35 years were randomized. GH was defined as blood pressure higher than 140/90 measured on two separate occasions, more than 6 hours apart, without the presence of protein in the urine and diagnosed after 20 weeks of gestation.
Women with multiple pregnancies, cervical insufficiency, vaginal bleeding, heart disease, systemic lupus erythematosus, kidney failure, and neurologic disorders were excluded from the study. For inclusion in the study, pregnant women also could not be engaged in any supervised physical exercise, at the time of selection and when signing a free written informed consent term.
Pregnant women were randomized using an opaque sealed envelope that was sequentially numbered and statistically generated by a computer program. The envelope contained information about the random allocation group: group (A), engaged in aerobic exercise twice a week under the supervision of a physical therapist, and group (B), engaged in device guided breathing exercises. Both groups received antihypertensive medications. Random allocation of the subjects was performed by another investigator, who did not participate directly in the research study.
Exercise program for group (A) The therapist advised all participants to drink a plenty of water before and after the exercise session to avoid excessive loss of body water during the session. Pregnant women were instructed to have a light meal about one hour before the performance of exercise and to wear comfortable clothes.
Participants in this group were given a Low-Intensity Aerobic Exercise with Borg scale RPE at 11. Participants were asked to maintain this intensity of rate of perceived exertion throughout the 45 minutes' duration of the aerobic training.
During the training session, the therapist stood near the patient to observe and detect signs of stopping the exercise. The therapist continuously asked the patient if she felt pain, dizzy or shortens of breath.
Device guided breathing for group (B) The FDA approved the Resperate device as an adjunct anti-hypertensive treatment approach that guides home users to alter their breathing rate in response to instructed signals .
At the beginning the researcher explained the device and study procedures to every participant of group (B).The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
The participant is instructed to alter their breathing rate, aiming for up to 10 breaths per minute, in response to a melody played to them via the asked to use the device for at least 40 min per week, with each session lasting at least 10 min .
All pregnant females of both groups were requested to maintain routine lifestyle habits with regard to diet intake throughout the study. All blood pressure measurements were conducted during the morning hours. Arterial blood pressure was measured using a standard mercury sphygmomanometer with appropriate cuff size, after subjects had rested in the sitting position for at least 5 minutes. BP was measured and presented at 20 week gestation and week-36 of gestation. Two readings were taken at 2 minutes interval, and the average values were used as the baseline value.
- Conditions
- Hypertension ,Pregnancy
- Being tested
- Aerobic exercise, Device guided breathing
- Keywords
- Hypertension, Pregnancy, Aerobic exercise, Device guided breathing
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
a Low-Intensity Aerobic Exercise with Borg scale RPE at 11.
Device guided breathingDevice
The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise group | Experimental | The therapist advised all participants of this group to drink a plenty of water before and after the exercise session to avoid excessive loss of body water during the session. Pregnant women were instructed to have a light meal about one hour before the performance of exercise and to wear comfortable clothes.
Participants in this group were given a Low-Intensity Aerobic Exercise with Borg scale RPE at 11. Participants were asked to maintain this intensity of rate of perceived exertion throughout the 45 minutes' duration of the aerobic training.
During the training session, the therapist stood near the patient to observe and detect signs of stopping the exercise. The therapist continuously asked the patient if she felt pain, dizzy or shortens of breath.
No complications were observed during physical exercise sessions, for example, hypertensive crisis, hypotension, hyperthermia, musculoskeletal lesions, or other complications identified that demanded interruption of the exercise. Receives: Other: Aerobic exercise |
| Device guided breathing group | Active comparator | At the beginning the researcher explained the device and study procedures to every participant of this group .The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
The participant is instructed to alter their breathing rate, aiming for up to 10 breaths per minute, in response to a melody played to them via the asked to use the device for at least 40 min per week, with each session lasting at least 10 min Receives: Device: Device guided breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood pressure
Change in Arterial blood pressure was measured using a standard mercury
Measured: from enrollment to end of treatment at 36 week gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ,PregnancyStudies 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
- A total of 75 participants were initially screened. After the screening process, 60 participants were found to be eligible to participate in the study. In total, 50 (100%) participants completed the treatment program
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Aly Elbandrawy, Cairo University
- Investigators
- Asmaa M Elbandrawy, Assis prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352374
- Sponsor's protocol ID
- Cairo university P.T
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: journal publication, Google Scholar, ResearchGate, LinkedIn
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercises Versus Device Guided Breathing on Gestational Hypertension
- ClinicalTrials.gov ID
- NCT04352374
- Acronym / sponsor ID
- Cairo university P.T
- Conditions
- Hypertension ,Pregnancy
- Keywords
- Hypertension, Pregnancy, Aerobic exercise, Device guided breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 20 Apr 2020 (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.
Aim To compare between the effect of aerobic exercise versus device guided breathing (DGB) on blood pressure in gestational hypertensive patients. Participants and Methods Randomized controlled trial, which included 60 singleton pregnant women (at 21-week gestation) diagnosed with gestational hypertension. They were divided into two groups: group (A) received aerobic exercise with a treadmill twice a week, for 45 minutes; and group (B) received Device guided breathing exercise for at least 40 min per week, with each session lasting at least 10 min. Assessment of the systolic blood pressure (SBP) and diastolic blood pressure (DBP) for all participants in the two studied groups (A, B) was carried out at begining of the study and at week-36 of gestation with mercury column sphygmomanometer.
Detailed description
Sixty singleton pregnant women, diagnosed with gestational hypertension (GH) at 21- week of gestation, and aged between 25-35 years were randomized. GH was defined as blood pressure higher than 140/90 measured on two separate occasions, more than 6 hours apart, without the presence of protein in the urine and diagnosed after 20 weeks of gestation.
Women with multiple pregnancies, cervical insufficiency, vaginal bleeding, heart disease, systemic lupus erythematosus, kidney failure, and neurologic disorders were excluded from the study. For inclusion in the study, pregnant women also could not be engaged in any supervised physical exercise, at the time of selection and when signing a free written informed consent term.
Pregnant women were randomized using an opaque sealed envelope that was sequentially numbered and statistically generated by a computer program. The envelope contained information about the random allocation group: group (A), engaged in aerobic exercise twice a week under the supervision of a physical therapist, and group (B), engaged in device guided breathing exercises. Both groups received antihypertensive medications. Random allocation of the subjects was performed by another investigator, who did not participate directly in the research study.
Exercise program for group (A) The therapist advised all participants to drink a plenty of water before and after the exercise session to avoid excessive loss of body water during the session. Pregnant women were instructed to have a light meal about one hour before the performance of exercise and to wear comfortable clothes.
Participants in this group were given a Low-Intensity Aerobic Exercise with Borg scale RPE at 11. Participants were asked to maintain this intensity of rate of perceived exertion throughout the 45 minutes' duration of the aerobic training.
During the training session, the therapist stood near the patient to observe and detect signs of stopping the exercise. The therapist continuously asked the patient if she felt pain, dizzy or shortens of breath.
Device guided breathing for group (B) The FDA approved the Resperate device as an adjunct anti-hypertensive treatment approach that guides home users to alter their breathing rate in response to instructed signals .
At the beginning the researcher explained the device and study procedures to every participant of group (B).The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
The participant is instructed to alter their breathing rate, aiming for up to 10 breaths per minute, in response to a melody played to them via the asked to use the device for at least 40 min per week, with each session lasting at least 10 min .
All pregnant females of both groups were requested to maintain routine lifestyle habits with regard to diet intake throughout the study. All blood pressure measurements were conducted during the morning hours. Arterial blood pressure was measured using a standard mercury sphygmomanometer with appropriate cuff size, after subjects had rested in the sitting position for at least 5 minutes. BP was measured and presented at 20 week gestation and week-36 of gestation. Two readings were taken at 2 minutes interval, and the average values were used as the baseline value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 75 participants were initially screened. After the screening process, 60 participants were found to be eligible to participate in the study. In total, 50 (100%) participants completed the treatment program
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise group | Experimental | Other: Aerobic exerciseThe therapist advised all participants of this group to drink a plenty of water before and after the exercise session to avoid excessive loss of body water during the session. Pregnant women were instructed to have a light meal about one hour before the performance of exercise and to wear comfortable clothes. Participants in this group were given a Low-Intensity Aerobic Exercise with Borg scale RPE at 11. Participants were asked to maintain this intensity of rate of perceived exertion throughout the 45 minutes' duration of the aerobic training. During the training session, the therapist stood near the patient to observe and detect signs of stopping the exercise. The therapist continuously asked the patient if she felt pain, dizzy or shortens of breath. No complications were observed during physical exercise sessions, for example, hypertensive crisis, hypotension, hyperthermia, musculoskeletal lesions, or other complications identified that demanded interruption of the exercise. |
| Device guided breathing group | Active comparator | Device: Device guided breathingAt the beginning the researcher explained the device and study procedures to every participant of this group .The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest. The participant is instructed to alter their breathing rate, aiming for up to 10 breaths per minute, in response to a melody played to them via the asked to use the device for at least 40 min per week, with each session lasting at least 10 min |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sixty singleton pregnant women, diagnosed with gestational hypertension (GH) at 21- week of gestation, and aged between 25-35 years were randomized. GH was defined as blood pressure higher than 140/90 measured on two separate occasions, more than 6 hours apart, without the presence of protein in the urine and diagnosed after 20 weeks of gestation.
Key exclusion criteria (1 listed)
- Women with multiple pregnancies, cervical insufficiency, vaginal bleeding, heart disease, systemic lupus erythematosus, kidney failure, and neurologic disorders were excluded from the study. For inclusion in the study, pregnant women also could not be engaged in any supervised physical exercise, at the time of selection and when signing a free written informed consent term.
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 |
|---|---|---|
| Aerobic exercisea Low-Intensity Aerobic Exercise with Borg scale RPE at 11. | Other | Aerobic exercise group |
| Device guided breathingThe device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest. | Device | Device guided breathing group |
Primary outcome
Arterial blood pressure
Time frame: from enrollment to end of treatment at 36 week gestation
Change in Arterial blood pressure was measured using a standard mercury
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 20 Apr 2020.
- Individual participant dataSharing planned: No. journal publication, Google Scholar, ResearchGate, LinkedIn
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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.
Asmaa M Elbandrawy, Assis prof principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Device guided breathing in people with Hypertension ,Pregnancy, 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 1 inclusion and 1 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 20 Apr 2020. 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?
Arterial blood pressure (time frame: from enrollment to end of treatment at 36 week gestation). 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 20 Apr 2020.