Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension

August 23, 2023 updated by: AMIR IQBAL, King Saud University

Effect of Slow Breathing and Progressive Muscle Relaxation Technique in Individual With Essential Hypertension: a Randomized Controlled Trial

Primary hypertension, also called essential hypertension, is a rise in blood pressure (BP) with no identifiable cause. The most prevalent form of hypertension is essential hypertension, which involves 95% of patients with hypertension.Progressive muscle relaxation (PMR) is learning to relax some groups of muscles while paying attention to the feelings connected with both the tense and relaxed states.It is generally established that regular slow (deep) breathing exercises enhance respiratory and cardiovascular function by enhancing parasympathetic tone and reducing sympathetic activity, thus reducing BP, heart rate, respiratory rate, and stress levels in hypertensive patients. This study aimed to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

Study Overview

Detailed Description

From the previously published literature, it is obvious that both slow breathing and PMR and slow breathing is effective in patients with essential hypertension. However, no studies are available on the combined effect of these two techniques. So, the study aims to investigate the combined effect of slow breathing and PMR technique on BP, heart rate, respiratory rate, and anxiety in patients diagnosed with essential hypertension.

Sixty-four participants diagnosed with essential hypertension were randomly allocated into four groups (Slow breathing (SB), PMR, SB+PMR, Control) with 16 subjects in each. Baseline BP, HR, RR and perceived stress scale were taken. All three-intervention groups underwent 30 minutes of training three days before the day of the intervention. The intervention consisted of 30 minutes, pre, mid and post-intervention BP, HR, RR and Perceived Stress (PS) were measured. The control group rested for 30 minutes. Pre, mid and post-rest measurements of BP, HR, RR and PS were taken.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riyadh 11433
      • Riyadh, Riyadh 11433, Saudi Arabia, 10219
        • Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with essential hypertension, a diastolic BP between 90 to 109mm of Hg, a systolic BP of more than 140mm of Hg,
  • Aged between 30 to 60 years, and
  • Self co-operation.

Exclusion Criteria:

  • Participants with secondary hypertension, any physical abnormalities that may disturb the exercise intervention,
  • Participant who cannot perform any relaxation or breathing exercises, and
  • Non-cooperation of participants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBE Group
Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group.

Slow Breathing Exercise (SBE) delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to make six breaths per minute for 30 minutes per session, twice a week for 4 weeks.

Experimental: PMR Group
Progressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group. It included 16-participants for the study.

Progressive Muscle Relaxation (PMR) Technique delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to complete all sixteen steps of PMR technique for 30 minutes per session, twice a week for 4 weeks.

Experimental: Combined Group
Sixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study.

Slow Breathing Exercise (SBE) delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to make six breaths per minute for 30 minutes per session, twice a week for 4 weeks.

Progressive Muscle Relaxation (PMR) Technique delivered in a relaxed supine posture on a couch with keeping the feel flat and knee flexed to 90 degree.

Participants were instructed to complete all sixteen steps of PMR technique for 30 minutes per session, twice a week for 4 weeks.

No Intervention: Control Group
No intervention was received/performed by the sixteen participants of the control group in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Rate (RR)
Time Frame: 8 Weeks
RR was measured manually as the number of breaths a participant takes per minute.
8 Weeks
Systolic Blood Pressure (SBP)
Time Frame: 8 Weeks
SBP was measured using a portable electronic sphygmomanometer.
8 Weeks
Diastolic Blood Pressure (DBP)
Time Frame: 8 Weeks
DBP was measured using a portable electronic sphygmomanometer.
8 Weeks
Heart Rate (HR)
Time Frame: 8 Weeks
Heart Rate was measured using a portable electronic sphygmomanometer.
8 Weeks
Perceived Stress (PS)
Time Frame: 8 Weeks
Perceived Stress was assessed using the perceived stress scale (PSS) with ten items, each with a five-point Likert scale (where a score of 0 indicates "never," a score of 1 indicates "nearly never," a score of 2 "occasionally," a score of 3 "very often," and a score of 4 "often").
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: AMIR IQBAL, MPT, King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

October 26, 2019

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RRC-2019-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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