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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05828615
Other study ID # Rec/01385 Rida Kanwal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2023
Est. completion date August 30, 2023

Study information

Verified date August 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Intervention

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).
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).

Locations

Country Name City State
Pakistan Punjab medical center Gujarat. Gujrat Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 weeks
Primary 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. 12 weeks
Primary 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. 12 weeks
Primary 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. 12 weeks
Secondary 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. 8 weeks
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