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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Slow Breathing Exercise (SBE)
Progressive Muscle Relaxation (PMR) Technique
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

SBE Group

PMR Group

Combined Group

Control Group

Arm Description

Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group.

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

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

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

Outcomes

Primary Outcome Measures

Systolic Blood Pressure (SBP)
SBP was measured using a portable electronic sphygmomanometer.
Diastolic Blood Pressure (DBP)
DBP was measured using a portable electronic sphygmomanometer.
Heart Rate (HR)
Heart Rate was measured using a portable electronic sphygmomanometer.
Respiratory Rate (RR)
RR was measured manually as the number of breaths a participant takes per minute.
Perceived Stress (PS)
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").

Secondary Outcome Measures

Full Information

First Posted
January 5, 2023
Last Updated
August 23, 2023
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05684666
Brief Title
Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension
Official Title
Effect of Slow Breathing and Progressive Muscle Relaxation Technique in Individual With Essential Hypertension: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBE Group
Arm Type
Experimental
Arm Description
Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group.
Arm Title
PMR Group
Arm Type
Experimental
Arm Description
Progressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group. It included 16-participants for the study.
Arm Title
Combined Group
Arm Type
Experimental
Arm Description
Sixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention was received/performed by the sixteen participants of the control group in this study.
Intervention Type
Other
Intervention Name(s)
Slow Breathing Exercise (SBE)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Progressive Muscle Relaxation (PMR) Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Systolic Blood Pressure (SBP)
Description
SBP was measured using a portable electronic sphygmomanometer.
Time Frame
8 Weeks
Title
Diastolic Blood Pressure (DBP)
Description
DBP was measured using a portable electronic sphygmomanometer.
Time Frame
8 Weeks
Title
Heart Rate (HR)
Description
Heart Rate was measured using a portable electronic sphygmomanometer.
Time Frame
8 Weeks
Title
Respiratory Rate (RR)
Description
RR was measured manually as the number of breaths a participant takes per minute.
Time Frame
8 Weeks
Title
Perceived Stress (PS)
Description
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").
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIR IQBAL, MPT
Organizational Affiliation
King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
City
Riyadh
State/Province
Riyadh 11433
ZIP/Postal Code
10219
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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