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Completed

NCT Number: NCT05828615

Breathing Exercise in Pregnancy-induced Hypertension

To determine the effects of Breathing control vs Alternate nostril breathing on maternal cardiovascular parameters in pregnancy and to determine the effect of breathing control vs Alternate nostril breathing on Fetal Heart rate. Many evidence-based studies show breathing exercises have beneficial and useful effects on the hypertensive population and also have positive effects on pregnancy-induced hypertension.

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Key information

Conditions

Pregnancy Induced Hypertension Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Punjab medical center Gujarat.

Dhok Gujra, Punjab Province, 54560, Pakistan

About this study

Many breathing interventions are used for pregnancy-induced hypertension but the comparison is limited between two breathing techniques. In this study, a comparison will be carried out between evidence-based breathing techniques including breathing control and alternate nostril breathing to see which of these two exercises gives the best effects on females with pregnancy-induced hypertension.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females with 3rd-trimester pregnancies included
  • BMI<3
  • Diagnosed pregnancy-induced HTN

Exclusion criteria

  • An exaggerated response to exercise on BP ( 160/110 mmHg )
  • Uncontrolled Diabetics or asthma
  • Cardiac diseases
  • Orthopedic complications
  • Using anti-epileptic drugs and
  • Hyperthyroidism or hypothyroidism

Treatment and study plan

Group A

Other

Close your eyes and exhale through your left nostril fully and slowly, once you have exhaled completely, release your right nostril and place your ring finger on the left nostril.

Breathe in deeply and slowly from the right side. Make sure your breath is smooth and continuous. Aerobics exercises (Walking): 3-5 days per week at moderate intensity, of approximately 30 minutes.

Start slowly and gradually increase your walking pace over 3 minutes until the activity feels moderate (slightly increased breathing, but should still be able to talk.

Walk at a moderate pace for about 10 minutes the first then gradually increase time with RPE(8-9).

Other names: Alternate nostril breathing

Group B

Other

The position of the woman should be relaxed and comfortable e.g., crock lying, sitting, standing position. Place one hand on chest and other on stomach and close eyes to relax and focus on breathing. Slowly breathe in through nose with your closed mouth.Breathe out through your nose and try to use as small effort as possible and make your breaths slow, relaxed and smooth.

Aerobics exercises (Walking): 3-5 days per week at moderate intensity, of approximately 30 minutes.

Start slowly and gradually increase your walking pace over 3 minutes until the activity feels moderate (slightly increased breathing, but should still be able to talk.

Walk at a moderate pace for about 10 minutes the first then gradually increase time with RPE(8-9).

Primary outcomes

  1. Blood Pressure

    Time frame: 12 weeks

    Changes from baseline to 4 weeks after the intervention, time of discharge from the hospital, and, 40 days postpartum, measured through a sphygmomanometer. Blood pressure is measured in millimeters of mercury (mm Hg). A blood pressure measurement has two numbers Systolic and Diastolic. The patients are classified according to the range as follows. Hypertension stage 1 SYSTOLIC (mm of Hg): 131-139, DIASTOLIC (mm of Hg): 81-89 and stage 2 SYSTOLIC (mm of Hg): 140 and above, DIASTOLIC (mm of Hg): 90 and above

  2. Oxygen Saturation

    Time frame: 12 weeks

    Changes from baseline to 4 weeks after the intervention, time of discharge from the hospital, and, 40 days postpartum, measured through a pulse oximeter. It measures how much oxygen is in person's blood. It is a small device, clips onto a finger, earlobe or another part of the body. Oxygen saturation level of 95% is considered typical for most healthy people, a level of 92% or lower can indicate potential hypoxemia, which is a seriously low level of oxygen in the blood.

  3. Functional capacity

    Time frame: 12 weeks

    Changes from baseline to 4 weeks after the intervention, and, 40 days postpartum, measured through 6 min walk test (6 MWT) used to measure Functional capacity. It is a submaximal exercise test that can aid in assessing the functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters that an individual covers in 6 min without any support.

  4. Quality of life(QOL) (postpartum)

    Time frame: 12 weeks

    Changes from baseline to 4 weeks after intervention and 40 days postpartum measured through Short Form 36 Health Survey Questionnaire (SF-36) that is used to indicate the health status of particular population. Its consists of eight scaled scores, which are weighted sums of the questions in each section. Each scale is directly transformed into a 0-100 scale on assumption that every question carries equal weight and lower score the more disability.

Secondary outcomes

  1. Fetal Heart rate

    Time frame: 8 weeks

    Changes from baseline to Changes from baseline to 4 weeks after intervention and time of delivery measured through Doppler ultrasound (US).This is a method that uses a device to listen and record heartbeat of baby through abdomen. The rate and pattern of heart rate of baby shown on a screen and printed on paper. The average fetal heart rate is between 110 and 160 beats per minute.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Breathing Control vs Alternate Nostril Breathing on Maternal Cardiovascular Parameters in Pregnancy Induced Hypertension

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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