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Completed

NCT Number: NCT06131528

Relaxation Breathing Exercises Effects Among Hypertensive Patients

The objective of this study will be to compare the effects of Relaxation Breathing Exercises on Cardiovascular Parameters among Hypertensive patients. This study will be a Randomized Clinical trial. Data will be collected from Allied and DHQ hospital Faisalabad. One group will receive Breathing Exercises and other group will receive usual care. All subjects will receive a total of three treatment sessions per week over the period of 12 weeks. Outcome will be measured at baseline, 6th and 12th week of treatment.

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Key information

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

About this study

Hypertension is the leading risk factor for cardiovascular disease and leading cause of premature death globally. Around the world, more than a billion adults suffer with hypertension, which can impact up to 45% of the adult population. All socioeconomic and economic classes experience significant rates of hypertension, and these rates increase with age, reaching up to 60% of people over the age of 60. The Lancet issued a global health survey report in 2010 that included patient data from 67 different countries and identified hypertension as the leading cause of mortality and disability-adjusted life years since 1990. HTN alone accounts for more cardiovascular disease-related deaths in the US than any other modifiable risk factor and is the second-leading preventable cause of death overall, after cigarette smoking. According to recent predictions, there may be up to 1.5 billion hypertensive patients worldwide by 2025, an increase of up to 15%.

Deep breathing exercises involve using a breathing pattern with less than 10 breaths per minute and a lengthy intake period. Benefits of slow, deep breathing exercises include a reduction in pain and stress levels, as well as the management of anxiety and panic. Exercise that involves deep, slow breathing can lower blood pressure, oxygen consumption, metabolism, heartbeat frequency, and frequency of breathing and heartbeat.

Exercises that involve deep breathing can improve vagal tone, stimulate stretch receptors, and lower sympathetic activity. Blood pressure and heart rate are consequently lowered. Shallow breathing increases baroreflex sensitivity and the Vulture-Breuer response, which reduces heart rate and blood pressure.

Diaphragmatic breathing exercises alone have no or little effect. So, the purpose of this study is to combine diaphragmatic breathing exercises with slow deep breathing, alternate nostril breathing and pursed lip breathing to gain its maximum effects and to reduce the stress that is main factor of hypertension

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age group: Male and female aged 25 - 45 and above without any other uncontrolled cardiovascular or other diseases, with or without antihypertensive medications.
  • Patients who have essential hypertension or stage 1 hypertension.
  • SBP between 120 and 139 mmHg
  • DBP between 80 - 89 mmHg
  • An independent lifestyle should be stable on antihypertensive treatment for a minimum of 2 months before the study and no change in medications during participation in the trial.
  • Non-smokers
  • None was involved in competitive sports activities

Exclusion criteria

  • There are signs of secondary hypertension, diabetes mellitus, cardiac disease and pregnancy.
  • In use of beta-blockers or centrally acting sympatholytic agents
  • 3 or more antihypertensive drugs
  • Pregnant women
  • Blood pressure greater 180/110 mmHg
  • Recent major surgery or admission within 1 year
  • Patients with a BMI >30 kg/ m2

Treatment and study plan

Relaxation Breathing Exercises Group

Other

This group will preform Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing

Usual Care Group

Other

The control group received lifestyle modifications that are an important part of hypertension management

Primary outcomes

  1. 6-minute walk test (6MWT)

    Time frame: Baseline; 6th Week; 12th Week

    It is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as PAH. The 6MWT measures how far a patient can walk in 6 minutes. Walking is an activity performed every day by most patients except for those most severely limited. By assessing patients' ability to exercise, the 6MWT provides a global assessment of respiratory, cardiovascular, neuromuscular, and cognitive function. The 6MWT does not differentiate what limits the patient nor does it assess maximal exercise capacity. Instead, the 6MWT allows the patient to exercise at a daily functional level and is a useful tool for assessing severity of disease, and increasing walk distance correlates with a subjective improvement in dyspnea

  2. Blood Pressure Measurements (SBP & DBP)

    Time frame: Baseline; 6th Week; 12th Week

    An appropriately sized cuff for the arm circumference was installed on the non-dominant arm. Blood pressure was measured every 20 minutes by 24 hours, and awake and sleep periods were determined according to information provided by the patients, the following are 7 strategies recommended by the AHA/AMA for accurate attainment of BP: 1) no conversation, 2) empty bladder, 3) use correct cuff size, 4) place BP cuff on bare arm, 5) support arm at heart level, 6) keep legs uncrossed, and 7) support back and feet

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Relaxation Breathing Exercises on Cardiovascular Parameters Among Hypertensive Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2023
Registry last updated
Apr 19, 2024

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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