Ignite Creation Date:
2024-05-06 @ 2:33 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04352374
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2020-04-12
Brief Title:
Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Aerobic Exercises Versus Device Guided Breathing on Gestational Hypertension
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 14090 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 BThe device consists of a control box headphones and a respiratory rate monitor attached as a sensor belt around the users 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
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 BThe device consists of a control box headphones and a respiratory rate monitor attached as a sensor belt around the users 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None