Aerobic Exercises vs Device Guided Breathing on Gestational Hypertension

NCT04352374 | Completed

• 1 other identifier: Cairo university P.T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension ,Pregnancy

Keywords

Hypertension; Pregnancy; Aerobic exercise; Device guided breathing

Outcome Measures

Primary Outcomes (1)

• Arterial blood pressure

  Change in Arterial blood pressure was measured using a standard mercury

  from enrollment to end of treatment at 36 week gestation

Study Arms (2)

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.

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

Device: Device guided breathing

Interventions

Aerobic exercise OTHER

a Low-Intensity Aerobic Exercise with Borg scale RPE at 11.

Aerobic exercise group

Device guided breathing DEVICE

The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.

Device guided breathing group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Gestational hypertension
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Dokki, 12612, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Asmaa M Elbandrawy, Assis prof

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof faculty of Physical Therapy

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 20, 2020
• Study Start: January 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)