Breathing Exercise in Pregnancy-induced Hypertension

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828615
Collaborator
(none)
14
1
2
5
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group A
  • Other: Group B
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effects of Breathing Control vs Alternate Nostril Breathing on Maternal Cardiovascular Parameters in Pregnancy Induced Hypertension
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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).

    Outcome Measures

    Primary Outcome Measures

    1. Blood Pressure [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 [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 [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) [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 Outcome Measures

    1. Fetal Heart rate [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Punjab medical center Gujarat. Gujrāt Punjab Pakistan 54560

    Sponsors and Collaborators

    • Riphah International University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05828615
    Other Study ID Numbers:
    • Rec/01385 Rida Kanwal
    First Posted:
    Apr 25, 2023
    Last Update Posted:
    Apr 25, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 25, 2023