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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684666
Other study ID # RRC-2019-07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 21, 2019
Est. completion date October 26, 2019

Study information

Verified date August 2023
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 26, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Slow Breathing Exercise (SBE)
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
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.

Locations

Country Name City State
Saudi Arabia Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University Riyadh Riyadh 11433

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic Blood Pressure (SBP) SBP was measured using a portable electronic sphygmomanometer. 8 Weeks
Primary Diastolic Blood Pressure (DBP) DBP was measured using a portable electronic sphygmomanometer. 8 Weeks
Primary Heart Rate (HR) Heart Rate was measured using a portable electronic sphygmomanometer. 8 Weeks
Primary Respiratory Rate (RR) RR was measured manually as the number of breaths a participant takes per minute. 8 Weeks
Primary 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"). 8 Weeks
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