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Breathing Exercise in Pregnancy-induced Hypertension

Primary Purpose

Pregnancy Induced Hypertension

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Induced Hypertension focused on measuring Breathing control, Alternate nostril breathing, Maternal cardiovascular parameters, Fetal Heart rate

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Punjab medical center Gujarat.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Alternate nostril breathing exercise 2 times a day, 10 min duration of exercise each time, for 5 days

Breathing control exercise 2 times a day, 10 min duration of exercise each time, for 5 days

Outcomes

Primary Outcome Measures

Blood Pressure
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
Oxygen Saturation
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.
Functional capacity
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.
Quality of life(QOL) (postpartum)
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 Outcome Measures

Fetal Heart rate
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.

Full Information

First Posted
April 12, 2023
Last Updated
August 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05828615
Brief Title
Breathing Exercise in Pregnancy-induced Hypertension
Official Title
Effects of Breathing Control vs Alternate Nostril Breathing on Maternal Cardiovascular Parameters in Pregnancy Induced Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Induced Hypertension
Keywords
Breathing control, Alternate nostril breathing, Maternal cardiovascular parameters, Fetal Heart rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Alternate nostril breathing exercise 2 times a day, 10 min duration of exercise each time, for 5 days
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Breathing control exercise 2 times a day, 10 min duration of exercise each time, for 5 days
Intervention Type
Other
Intervention Name(s)
Group A
Other Intervention Name(s)
Alternate nostril breathing
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Group B
Intervention Description
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 Outcome Measure Information:
Title
Blood Pressure
Description
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
Time Frame
12 weeks
Title
Oxygen Saturation
Description
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.
Time Frame
12 weeks
Title
Functional capacity
Description
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.
Time Frame
12 weeks
Title
Quality of life(QOL) (postpartum)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fetal Heart rate
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Punjab medical center Gujarat.
City
Gujrāt
State/Province
Punjab
ZIP/Postal Code
54560
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27186213
Citation
Aalami M, Jafarnejad F, ModarresGharavi M. The effects of progressive muscular relaxation and breathing control technique on blood pressure during pregnancy. Iran J Nurs Midwifery Res. 2016 May-Jun;21(3):331-6. doi: 10.4103/1735-9066.180382.
Results Reference
background
PubMed Identifier
33463384
Citation
Felton M, Hundley VA, Grigsby S, McConnell AK. Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol. Hypertens Pregnancy. 2021 Feb;40(1):81-87. doi: 10.1080/10641955.2020.1869250. Epub 2021 Jan 19.
Results Reference
background
PubMed Identifier
32619194
Citation
Tsakiridis I, Bakaloudi DR, Oikonomidou AC, Dagklis T, Chourdakis M. Exercise during pregnancy: a comparative review of guidelines. J Perinat Med. 2020 Jul 28;48(6):519-525. doi: 10.1515/jpm-2019-0419.
Results Reference
background

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Breathing Exercise in Pregnancy-induced Hypertension

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