CClinicalTrials.gg
CompletedNCT06131528Updated Apr 19, 2024

Relaxation Breathing Exercises Effects Among Hypertensive Patients

An interventional study of Relaxation Breathing Exercises Group and Usual Care Group in Hypertension, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Relaxation Breathing Exercise
  • Cardiovascular parameters
  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Relaxation Breathing Exercises Group

    This group preformed Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing on alternative pattern for 10 minutes to 30 minutes. These exercises are performed daily with 6 breaths per min. The minimum duration was 3 min for one session.

    Other: Relaxation Breathing Exercises Group

  • Active comparator
    Usual Care Group

    The control group received lifestyle modifications that are an important part of hypertension management and include weight reduction, following the DASH eating plan with sodium restrictions, daily physical activity, and moderate alcohol consumption. In addition, all patients should be advised to stop smoking to reduce the risk of cardiovascular diseases.

    Other: Usual Care Group

Interventions

  • OtherRelaxation Breathing Exercises Group

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

  • OtherUsual Care Group

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

06

What researchers measure

Primary outcomes

  1. 6-minute walk test (6MWT)

    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

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

  2. Blood Pressure Measurements (SBP & DBP)

    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

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

07

Study locations

1 site
  • Riphah Rehabilitation Clinic
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • Shaltout HA, Eggebeen J, Marsh AP, Brubaker PH, Laurienti PJ, Burdette JH, Basu S, Morgan A, Dos Santos PC, Norris JL, Morgan TM, Miller GD, Rejeski WJ, Hawfield AT, Diz DI, Becton JT, Kim-Shapiro DB, Kitzman DW. Effects of supervised exercise and dietary nitrate in older adults with controlled hypertension and/or heart failure with preserved ejection fraction. Nitric Oxide. 2017 Sep 30;69:78-90. doi: 10.1016/j.niox.2017.05.005. Epub 2017 May 23. PubMed 28549665 ↗
  • Lebedeva OD, Achilov AA, Mavlyanova ZF, Baranov AV, Achilova SA, Sanina NP, Fesyun AD, Rachin AP, Yakovlev MY, Terentev KV, Reverchuk IV, Velilyaeva AS, Maccarone MC, Masiero S. Is relaxation exercise therapy effective in the management of patients with severe arterial hypertension? Eur J Transl Myol. 2021 Dec 15;31(4):10327. doi: 10.4081/ejtm.2021.10327. PubMed 34911289 ↗
  • Su TT, Majid HA, Nahar AM, Azizan NA, Hairi FM, Thangiah N, Dahlui M, Bulgiba A, Murray LJ. The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial. BMC Public Health. 2014;14 Suppl 3(Suppl 3):S4. doi: 10.1186/1471-2458-14-S3-S4. Epub 2014 Nov 24. Erratum In: BMC Public Health. 2017 Nov 6;17(1):864. doi: 10.1186/s12889-017-4862-y. PubMed 25436830 ↗
  • Kundapur R, Modi B, Mary L, Manjula R, Santhosh P, Saxena D. A community-level educational intervention trail to study the impact of life style modification in control of hypertension and diabetes- A non-randomized trial (Before and after intervention study without control). J Family Med Prim Care. 2022 Nov;11(11):6759-6764. doi: 10.4103/jfmpc.jfmpc_2174_21. Epub 2022 Dec 16. PubMed 36993009 ↗
  • Cherfan M, Vallee A, Kab S, Salameh P, Goldberg M, Zins M, Blacher J. Unhealthy behaviors and risk of uncontrolled hypertension among treated individuals-The CONSTANCES population-based study. Sci Rep. 2020 Feb 5;10(1):1925. doi: 10.1038/s41598-020-58685-1. PubMed 32024888 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06131528
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
Oct 30, 2023
Primary completion
Jan 30, 2024
Completion
Feb 28, 2024
Last update
Apr 19, 2024

Study contacts

Danish Hassan, PhD*
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion