Relaxation Breathing Exercises Effects Among Hypertensive Patients

NCT06131528 | Completed

• 1 other identifier: RiphahIU Rida Ali
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Relaxation Breathing Exercise; Cardiovascular parameters; Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline; 6th Week; 12th Week

• 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

  Baseline; 6th Week; 12th Week

Study Arms (2)

Relaxation Breathing Exercises Group

EXPERIMENTAL

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

Usual Care Group

ACTIVE COMPARATOR

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

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

Relaxation Breathing Exercises Group

Usual Care Group OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• There are signs of secondary hypertension, diabetes mellitus, cardiac disease and pregnancy.
• In use of beta-blockers or centrally acting sympatholytic agents
• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah Rehabilitation Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 28549665 BACKGROUND

• 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.

  PMID: 34911289 BACKGROUND

• 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.

  PMID: 25436830 BACKGROUND

• 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.

  PMID: 36993009 BACKGROUND

• 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.

  PMID: 32024888 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Danish Hassan, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: October 30, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 28, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)