Breathing Exercise in Pregnancy-induced Hypertension

August 31, 2023 updated by: Riphah International University

Effects of Breathing Control vs Alternate Nostril Breathing on Maternal Cardiovascular Parameters 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Gujrāt, Punjab, Pakistan, 54560
        • Punjab medical center Gujarat.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Alternate nostril breathing exercise 2 times a day, 10 min duration of exercise each time, for 5 days
Other: Group A

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
Active Comparator: Group B
Breathing control exercise 2 times a day, 10 min duration of exercise each time, for 5 days
Other: Group B

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mehwish Waseem, MSPT(CPPT), Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec/01385 Rida Kanwal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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