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Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension

Primary Purpose

Hypertension ,Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise
Device guided breathing
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension ,Pregnancy focused on measuring Hypertension, Pregnancy, Aerobic exercise, Device guided breathing

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerobic exercise group

Device guided breathing group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Arterial blood pressure
Change in Arterial blood pressure was measured using a standard mercury

Secondary Outcome Measures

Full Information

First Posted
April 12, 2020
Last Updated
April 16, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04352374
Brief Title
Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension
Official Title
Effect of Aerobic Exercises Versus Device Guided Breathing on Gestational Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension ,Pregnancy
Keywords
Hypertension, Pregnancy, Aerobic exercise, Device guided breathing

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Device guided breathing group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
a Low-Intensity Aerobic Exercise with Borg scale RPE at 11.
Intervention Type
Device
Intervention Name(s)
Device guided breathing
Intervention Description
The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
Primary Outcome Measure Information:
Title
Arterial blood pressure
Description
Change in Arterial blood pressure was measured using a standard mercury
Time Frame
from enrollment to end of treatment at 36 week gestation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gestational hypertension
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa M Elbandrawy, Assis prof
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
State/Province
Dokki
ZIP/Postal Code
12612
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
journal publication, Google Scholar, ResearchGate, LinkedIn

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Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension

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