- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684666
Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension
Effect of Slow Breathing and Progressive Muscle Relaxation Technique in Individual With Essential Hypertension: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh 11433
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Riyadh, Riyadh 11433, Saudi Arabia, 10219
- Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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.
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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. |
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Experimental: PMR Group
Progressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group.
It included 16-participants for the study.
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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. |
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Experimental: Combined Group
Sixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study.
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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. |
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No Intervention: Control Group
No intervention was received/performed by the sixteen participants of the control group in this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Respiratory Rate (RR)
Time Frame: 8 Weeks
|
RR was measured manually as the number of breaths a participant takes per minute.
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8 Weeks
|
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Systolic Blood Pressure (SBP)
Time Frame: 8 Weeks
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SBP was measured using a portable electronic sphygmomanometer.
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8 Weeks
|
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Diastolic Blood Pressure (DBP)
Time Frame: 8 Weeks
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DBP was measured using a portable electronic sphygmomanometer.
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8 Weeks
|
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Heart Rate (HR)
Time Frame: 8 Weeks
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Heart Rate was measured using a portable electronic sphygmomanometer.
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8 Weeks
|
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Perceived Stress (PS)
Time Frame: 8 Weeks
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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").
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8 Weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AMIR IQBAL, MPT, King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2019-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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