Essential HypertensionNCT05684666
Effect of Breathing and Muscle Relaxation Technique in Individual With Essential Hypertension
A study testing Slow Breathing Exercise (SBE) and Progressive Muscle Relaxation (PMR) Technique in people with Essential Hypertension, run by King Saud University at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Slow Breathing Exercise (SBE) and Progressive Muscle Relaxation (PMR) Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Feb 2019to 26 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
Riyadh, Riyadh 11433, 10219
About this study
Official title: 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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Slow Breathing Exercise (SBE), Progressive Muscle Relaxation (PMR) Technique
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow Breathing Exercise (SBE)Other
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) TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SBE Group | Experimental | Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group. Receives: Other: Slow Breathing Exercise (SBE) |
| PMR Group | Experimental | Progressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group. It included 16-participants for the study. Receives: Other: Progressive Muscle Relaxation (PMR) Technique |
| Combined Group | Experimental | Sixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study. Receives: Other: Slow Breathing Exercise (SBE); Other: Progressive Muscle Relaxation (PMR) Technique |
| Control Group | No intervention | No intervention was received/performed by the sixteen participants of the control group in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SBP)
SBP was measured using a portable electronic sphygmomanometer.
Measured: 8 Weeks
Diastolic Blood Pressure (DBP)
DBP was measured using a portable electronic sphygmomanometer.
Measured: 8 Weeks
Heart Rate (HR)
Heart Rate was measured using a portable electronic sphygmomanometer.
Measured: 8 Weeks
Respiratory Rate (RR)
RR was measured manually as the number of breaths a participant takes per minute.
Measured: 8 Weeks
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").
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start21 Feb 2019
- Primary completion30 Sep 2019
- Study completion26 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT, Principal investigator, King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684666
- Sponsor's protocol ID
- RRC-2019-07
- Status last verified
- Aug 2023
- First submitted
- 5 Jan 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Slow Breathing and Progressive Muscle Relaxation Technique in Individual With Essential Hypertension: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05684666
- Acronym / sponsor ID
- RRC-2019-07
- Conditions
- Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 26 Oct 2019 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SBE Group | Experimental | Other: Slow Breathing Exercise (SBE)Slow Breathing Exercise (SBE) was performed by the participants of SBE group. Sixteen participants included in this group. |
| PMR Group | Experimental | Other: Progressive Muscle Relaxation (PMR) TechniqueProgressive Muscle Relaxation (PMR) Technique was performed by the participants of the PMR group. It included 16-participants for the study. |
| Combined Group | Experimental | Other: Slow Breathing Exercise (SBE), Other: Progressive Muscle Relaxation (PMR) TechniqueSixty participants from the combined group performed both Slow Breathing Exercise and Progressive Muscle Relaxation technique in this study. |
| Control Group | No intervention | –No intervention was received/performed by the sixteen participants of the control group in this study. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Combined Group, SBE Group |
| Progressive Muscle Relaxation (PMR) TechniqueProgressive 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. | Other | Combined Group, PMR Group |
Primary outcome
Systolic Blood Pressure (SBP)
Time frame: 8 Weeks
SBP was measured using a portable electronic sphygmomanometer.
Diastolic Blood Pressure (DBP)
Time frame: 8 Weeks
DBP was measured using a portable electronic sphygmomanometer.
Heart Rate (HR)
Time frame: 8 Weeks
Heart Rate was measured using a portable electronic sphygmomanometer.
Respiratory Rate (RR)
Time frame: 8 Weeks
RR was measured manually as the number of breaths a participant takes per minute.
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").
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMIR IQBAL, MPT principal investigator
King Saud University, Riyadh 11433, P.BOX 10219, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Breathing Exercise (SBE) and Progressive Muscle Relaxation (PMR) Technique in people with Essential Hypertension, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SBP) (time frame: 8 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.