Clinical trial NCT06131528: Relaxation Breathing Exercises Effects Among Hypertensive Patients
Official title: Effects of Relaxation Breathing Exercises on Cardiovascular Parameters Among Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Relaxation Breathing Exercise
Cardiovascular parameters
Hypertension
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: 6-minute walk test (6MWT)
timeFrame: Baseline; 6th Week; 12th Week
measure: Blood Pressure Measurements (SBP & DBP)
timeFrame: Baseline; 6th Week; 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Clinic
state: Punjab
Study officials:
affiliation: Riphah International University
name: Danish Hassan, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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