HypertensionNCT05158569
Comparison of Breathing Exercise for Hypertensive Patients
A study testing Slow breathing exercise group and Diaphragmatic breathing exercise group in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Slow breathing exercise group and Diaphragmatic breathing exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to 15 Mar 2022
- 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
- Patient having stage 1 hypertension, Diagnosed after 1 week BP charting
Who cannot join
- Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Diaphragmatic Breathing vs. Slow Breathing Techniques on Blood Pressure and Health-related Quality of Life in Adults With Stage 1 Hypertension
To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.
Read the detailed description
Literature reports that inspiratory muscle training is more effective in reducing Blood Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.
- Conditions
- Hypertension
- Being tested
- Slow breathing exercise group, Diaphragmatic breathing exercise group
- Keywords
- Stage 1 hypertension, Diaphragmatic breathing, Slow breathing, Quality of life
- Medical subject headings
- Hypertension, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow breathing exercise groupOther
The patient will be first asked to close one nostril with a thumb and slowly breathe in completely through the other for 6 seconds. This nostril will be then closed and the patient will exhale through the other nostril over a period of 6 seconds. These steps complete one breathing cycle. An attempt will be made to keep the breathing rate is about 5-6 breaths per minute. Such alternate nostril breathing cycles will be repeated continuously for a period of about 15 minutes (3 sets of 5 minutes) in one sitting.
Diaphragmatic breathing exercise groupOther
Patients would be instructed to Sit or lie down in a comfortable place and put their hands on their belly.
Relax the muscles in their neck and shoulders. Breathe in slowly through the nose, keeping their mouth closed. Feel the lungs fill with air and inflate like a balloon while their belly moves outward. Such breathing cycles will be repeated continuously for a period of about 15 (3 sets of 5 minutes) minutes in one sitting.
| Study group | Role | What they receive |
|---|---|---|
| Slow breathing exercise group | Experimental | Slow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks. Receives: Other: Slow breathing exercise group |
| Diaphragmatic breathing exercise group | Experimental | Diaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks. Receives: Other: Diaphragmatic breathing exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure is measured in millimeters of mercury (mm Hg). A blood pressure measurement has two numbers: The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats. The patients are classified according to the range as follows. Hypertension stage 1 SYSTOLIC (mm of Hg): 121-139 DIASTOLIC (mm of Hg): 81-89
Measured: 4 weeks
Secondary outcomes (1)
Health related Quality of life
Measured through EuroQOL-five-dimensional-three-level (EQ-5D-3L) questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start15 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158569
- Sponsor's protocol ID
- Rec/01091 Kamran khan
- Status last verified
- Sep 2022
- First submitted
- 13 Dec 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones CU, Sangthong B, Pachirat O, Jones DA. Slow breathing training reduces resting blood pressure and the pressure responses to exercise. Physiol Res. 2015;64(5):673-82. doi: 10.33549/physiolres.932950. Epub 2015 Mar 24.
PubMed 25804100Janet SK, Mangala Gowri P. Effectiveness of deep breathing exercise on blood pressure among patients with hypertension. Int J Pharma Bio Sci 2017; 8(1):B256-60.
Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.
PubMed 28626434
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Diaphragmatic Breathing vs. Slow Breathing Techniques on Blood Pressure and Health-related Quality of Life in Adults With Stage 1 Hypertension
- ClinicalTrials.gov ID
- NCT05158569
- Acronym / sponsor ID
- Rec/01091 Kamran khan
- Conditions
- Hypertension
- Keywords
- Stage 1 hypertension, Diaphragmatic breathing, Slow breathing, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 15 Dec 2021 (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.
To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.
Detailed description
Literature reports that inspiratory muscle training is more effective in reducing Blood Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Slow breathing exercise group | Experimental | Other: Slow breathing exercise groupSlow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks. |
| Diaphragmatic breathing exercise group | Experimental | Other: Diaphragmatic breathing exercise groupDiaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient having stage 1 hypertension, Diagnosed after 1 week BP charting
Key exclusion criteria (1 listed)
- Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives
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 groupThe patient will be first asked to close one nostril with a thumb and slowly breathe in completely through the other for 6 seconds. This nostril will be then closed and the patient will exhale through the other nostril over a period of 6 seconds. These steps complete one breathing cycle. An attempt will be made to keep the breathing rate is about 5-6 breaths per minute. Such alternate nostril breathing cycles will be repeated continuously for a period of about 15 minutes (3 sets of 5 minutes) in one sitting. | Other | Slow breathing exercise group |
| Diaphragmatic breathing exercise groupPatients would be instructed to Sit or lie down in a comfortable place and put their hands on their belly. Relax the muscles in their neck and shoulders. Breathe in slowly through the nose, keeping their mouth closed. Feel the lungs fill with air and inflate like a balloon while their belly moves outward. Such breathing cycles will be repeated continuously for a period of about 15 (3 sets of 5 minutes) minutes in one sitting. | Other | Diaphragmatic breathing exercise group |
Primary outcome
Blood Pressure
Time frame: 4 weeks
Blood pressure is measured in millimeters of mercury (mm Hg). A blood pressure measurement has two numbers: The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats. The patients are classified according to the range as follows. Hypertension stage 1 SYSTOLIC (mm of Hg): 121-139 DIASTOLIC (mm of Hg): 81-89
1 secondary outcome
Health related Quality of life
Time frame: 4 weeks
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 16 Sep 2022.
- Background: PubMed 25804100Jones CU, Sangthong B, Pachirat O, Jones DA. Slow breathing training reduces resting blood pressure and the pressure responses to exercise. Physiol Res. 2015;64(5):673-82. doi: 10.33549/physiolres.932950. Epub 2015 Mar 24.
- BackgroundJanet SK, Mangala Gowri P. Effectiveness of deep breathing exercise on blood pressure among patients with hypertension. Int J Pharma Bio Sci 2017; 8(1):B256-60.
- Background: PubMed 28626434Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.
- 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.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International University
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 group and Diaphragmatic breathing exercise group in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 1 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 16 Sep 2022. 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 Pakistan. 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?
Blood Pressure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158569, which also lists 3 linked publications.
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 16 Sep 2022.