Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension
Condition: Hypertension ,Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

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.
    

Intervention name(s): Aerobic exercise; Device guided breathing
Intervention type(s): Other; Device
Intervention description(s): a Low-Intensity Aerobic Exercise with Borg scale RPE at 11.; The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Pregnancy; Aerobic exercise; Device guided breathing