Hypertension ,Pregnancy Clinical Trial
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.
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.
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