HypertensionNCT06131528
Relaxation Breathing Exercises Effects Among Hypertensive Patients
A study testing Relaxation Breathing Exercises Group in people with Hypertension, run by Riphah International University at 1 site in Pakistan.
Trial summary
The objective of this study will be to compare the effects of Relaxation Breathing Exercises on Cardiovascular Parameters among Hypertensive patients. This study will be a Randomized Clinical trial. Data will be collected from Allied and DHQ hospital Faisalabad. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Relaxation Breathing Exercises Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2023to 28 Feb 2024
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: Male and female aged 25 - 45 and above without any other uncontrolled cardiovascular or other diseases, with or without antihypertensive medications.
- Patients who have essential hypertension or stage 1 hypertension.
- SBP between 120 and 139 mmHg
- DBP between 80 - 89 mmHg
- An independent lifestyle should be stable on antihypertensive treatment for a minimum of 2 months before the study and no change in medications during participation in the trial.
- Non-smokers
- None was involved in competitive sports activities
Who cannot join
- There are signs of secondary hypertension, diabetes mellitus, cardiac disease and pregnancy.
- In use of beta-blockers or centrally acting sympatholytic agents
- 3 or more antihypertensive drugs
- Pregnant women
- Blood pressure greater 180/110 mmHg
- Recent major surgery or admission within 1 year
- Patients with a BMI >30 kg/ m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Relaxation Breathing Exercises on Cardiovascular Parameters Among Hypertensive Patients
The objective of this study will be to compare the effects of Relaxation Breathing Exercises on Cardiovascular Parameters among Hypertensive patients. This study will be a Randomized Clinical trial. Data will be collected from Allied and DHQ hospital Faisalabad. One group will receive Breathing Exercises and other group will receive usual care. All subjects will receive a total of three treatment sessions per week over the period of 12 weeks. Outcome will be measured at baseline, 6th and 12th week of treatment.
Read the detailed description
Hypertension is the leading risk factor for cardiovascular disease and leading cause of premature death globally. Around the world, more than a billion adults suffer with hypertension, which can impact up to 45% of the adult population. All socioeconomic and economic classes experience significant rates of hypertension, and these rates increase with age, reaching up to 60% of people over the age of 60. The Lancet issued a global health survey report in 2010 that included patient data from 67 different countries and identified hypertension as the leading cause of mortality and disability-adjusted life years since 1990. HTN alone accounts for more cardiovascular disease-related deaths in the US than any other modifiable risk factor and is the second-leading preventable cause of death overall, after cigarette smoking. According to recent predictions, there may be up to 1.5 billion hypertensive patients worldwide by 2025, an increase of up to 15%.
Deep breathing exercises involve using a breathing pattern with less than 10 breaths per minute and a lengthy intake period. Benefits of slow, deep breathing exercises include a reduction in pain and stress levels, as well as the management of anxiety and panic. Exercise that involves deep, slow breathing can lower blood pressure, oxygen consumption, metabolism, heartbeat frequency, and frequency of breathing and heartbeat.
Exercises that involve deep breathing can improve vagal tone, stimulate stretch receptors, and lower sympathetic activity. Blood pressure and heart rate are consequently lowered. Shallow breathing increases baroreflex sensitivity and the Vulture-Breuer response, which reduces heart rate and blood pressure.
Diaphragmatic breathing exercises alone have no or little effect. So, the purpose of this study is to combine diaphragmatic breathing exercises with slow deep breathing, alternate nostril breathing and pursed lip breathing to gain its maximum effects and to reduce the stress that is main factor of hypertension
- Conditions
- Hypertension
- Being tested
- Relaxation Breathing Exercises Group, Usual Care Group
- Keywords
- Relaxation Breathing Exercise, Cardiovascular parameters, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Breathing Exercises GroupOther
This group will preform Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing
Usual Care GroupOther
The control group received lifestyle modifications that are an important part of hypertension management
| Study group | Role | What they receive |
|---|---|---|
| Relaxation Breathing Exercises Group | Experimental | This group preformed Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing on alternative pattern for 10 minutes to 30 minutes. These exercises are performed daily with 6 breaths per min. The minimum duration was 3 min for one session. Receives: Other: Relaxation Breathing Exercises Group |
| Usual Care Group | Active comparator | The control group received lifestyle modifications that are an important part of hypertension management and include weight reduction, following the DASH eating plan with sodium restrictions, daily physical activity, and moderate alcohol consumption. In addition, all patients should be advised to stop smoking to reduce the risk of cardiovascular diseases. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test (6MWT)
It is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as PAH. The 6MWT measures how far a patient can walk in 6 minutes. Walking is an activity performed every day by most patients except for those most severely limited. By assessing patients' ability to exercise, the 6MWT provides a global assessment of respiratory, cardiovascular, neuromuscular, and cognitive function. The 6MWT does not differentiate what limits the patient nor does it assess maximal exercise capacity. Instead, the 6MWT allows the patient to exercise at a daily functional level and is a useful tool for assessing severity of disease, and increasing walk distance correlates with a subjective improvement in dyspnea
Measured: Baseline; 6th Week; 12th Week
Blood Pressure Measurements (SBP & DBP)
An appropriately sized cuff for the arm circumference was installed on the non-dominant arm. Blood pressure was measured every 20 minutes by 24 hours, and awake and sleep periods were determined according to information provided by the patients, the following are 7 strategies recommended by the AHA/AMA for accurate attainment of BP: 1) no conversation, 2) empty bladder, 3) use correct cuff size, 4) place BP cuff on bare arm, 5) support arm at heart level, 6) keep legs uncrossed, and 7) support back and feet
Measured: Baseline; 6th Week; 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start30 Oct 2023
- Primary completion30 Jan 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish Hassan, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131528
- Sponsor's protocol ID
- RiphahIU Rida Ali
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaltout HA, Eggebeen J, Marsh AP, Brubaker PH, Laurienti PJ, Burdette JH, Basu S, Morgan A, Dos Santos PC, Norris JL, Morgan TM, Miller GD, Rejeski WJ, Hawfield AT, Diz DI, Becton JT, Kim-Shapiro DB, Kitzman DW. Effects of supervised exercise and dietary nitrate in older adults with controlled hypertension and/or heart failure with preserved ejection fraction. Nitric Oxide. 2017 Sep 30;69:78-90. doi: 10.1016/j.niox.2017.05.005. Epub 2017 May 23.
PubMed 28549665Lebedeva OD, Achilov AA, Mavlyanova ZF, Baranov AV, Achilova SA, Sanina NP, Fesyun AD, Rachin AP, Yakovlev MY, Terentev KV, Reverchuk IV, Velilyaeva AS, Maccarone MC, Masiero S. Is relaxation exercise therapy effective in the management of patients with severe arterial hypertension? Eur J Transl Myol. 2021 Dec 15;31(4):10327. doi: 10.4081/ejtm.2021.10327.
PubMed 34911289Su TT, Majid HA, Nahar AM, Azizan NA, Hairi FM, Thangiah N, Dahlui M, Bulgiba A, Murray LJ. The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial. BMC Public Health. 2014;14 Suppl 3(Suppl 3):S4. doi: 10.1186/1471-2458-14-S3-S4. Epub 2014 Nov 24.
PubMed 25436830Kundapur R, Modi B, Mary L, Manjula R, Santhosh P, Saxena D. A community-level educational intervention trail to study the impact of life style modification in control of hypertension and diabetes- A non-randomized trial (Before and after intervention study without control). J Family Med Prim Care. 2022 Nov;11(11):6759-6764. doi: 10.4103/jfmpc.jfmpc_2174_21. Epub 2022 Dec 16.
PubMed 36993009Cherfan M, Vallee A, Kab S, Salameh P, Goldberg M, Zins M, Blacher J. Unhealthy behaviors and risk of uncontrolled hypertension among treated individuals-The CONSTANCES population-based study. Sci Rep. 2020 Feb 5;10(1):1925. doi: 10.1038/s41598-020-58685-1.
PubMed 32024888
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Relaxation Breathing Exercises on Cardiovascular Parameters Among Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06131528
- Acronym / sponsor ID
- RiphahIU Rida Ali
- Conditions
- Hypertension
- Keywords
- Relaxation Breathing Exercise, Cardiovascular parameters, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 14 Nov 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.
The objective of this study will be to compare the effects of Relaxation Breathing Exercises on Cardiovascular Parameters among Hypertensive patients. This study will be a Randomized Clinical trial. Data will be collected from Allied and DHQ hospital Faisalabad. One group will receive Breathing Exercises and other group will receive usual care. All subjects will receive a total of three treatment sessions per week over the period of 12 weeks. Outcome will be measured at baseline, 6th and 12th week of treatment.
Detailed description
Hypertension is the leading risk factor for cardiovascular disease and leading cause of premature death globally. Around the world, more than a billion adults suffer with hypertension, which can impact up to 45% of the adult population. All socioeconomic and economic classes experience significant rates of hypertension, and these rates increase with age, reaching up to 60% of people over the age of 60. The Lancet issued a global health survey report in 2010 that included patient data from 67 different countries and identified hypertension as the leading cause of mortality and disability-adjusted life years since 1990. HTN alone accounts for more cardiovascular disease-related deaths in the US than any other modifiable risk factor and is the second-leading preventable cause of death overall, after cigarette smoking. According to recent predictions, there may be up to 1.5 billion hypertensive patients worldwide by 2025, an increase of up to 15%.
Deep breathing exercises involve using a breathing pattern with less than 10 breaths per minute and a lengthy intake period. Benefits of slow, deep breathing exercises include a reduction in pain and stress levels, as well as the management of anxiety and panic. Exercise that involves deep, slow breathing can lower blood pressure, oxygen consumption, metabolism, heartbeat frequency, and frequency of breathing and heartbeat.
Exercises that involve deep breathing can improve vagal tone, stimulate stretch receptors, and lower sympathetic activity. Blood pressure and heart rate are consequently lowered. Shallow breathing increases baroreflex sensitivity and the Vulture-Breuer response, which reduces heart rate and blood pressure.
Diaphragmatic breathing exercises alone have no or little effect. So, the purpose of this study is to combine diaphragmatic breathing exercises with slow deep breathing, alternate nostril breathing and pursed lip breathing to gain its maximum effects and to reduce the stress that is main factor of hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation Breathing Exercises Group | Experimental | Other: Relaxation Breathing Exercises GroupThis group preformed Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing on alternative pattern for 10 minutes to 30 minutes. These exercises are performed daily with 6 breaths per min. The minimum duration was 3 min for one session. |
| Usual Care Group | Active comparator | Other: Usual Care GroupThe control group received lifestyle modifications that are an important part of hypertension management and include weight reduction, following the DASH eating plan with sodium restrictions, daily physical activity, and moderate alcohol consumption. In addition, all patients should be advised to stop smoking to reduce the risk of cardiovascular diseases. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age group: Male and female aged 25 - 45 and above without any other uncontrolled cardiovascular or other diseases, with or without antihypertensive medications.
- Patients who have essential hypertension or stage 1 hypertension.
- SBP between 120 and 139 mmHg
- DBP between 80 - 89 mmHg
- An independent lifestyle should be stable on antihypertensive treatment for a minimum of 2 months before the study and no change in medications during participation in the trial.
Key exclusion criteria (7 listed)
- There are signs of secondary hypertension, diabetes mellitus, cardiac disease and pregnancy.
- In use of beta-blockers or centrally acting sympatholytic agents
- 3 or more antihypertensive drugs
- Pregnant women
- Blood pressure greater 180/110 mmHg
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 |
|---|---|---|
| Relaxation Breathing Exercises GroupThis group will preform Relaxation Breathing Exercises that includes Slow Deep Breathing, Pursed lip Breathing, Deep Diaphragmatic Breathing and Alternate Nostril Breathing | Other | Relaxation Breathing Exercises Group |
| Usual Care GroupThe control group received lifestyle modifications that are an important part of hypertension management | Other | Usual Care Group |
Primary outcome
6-minute walk test (6MWT)
Time frame: Baseline; 6th Week; 12th Week
It is a standard method for measuring exercise capacity in patients with cardiopulmonary disease such as PAH. The 6MWT measures how far a patient can walk in 6 minutes. Walking is an activity performed every day by most patients except for those most severely limited. By assessing patients' ability to exercise, the 6MWT provides a global assessment of respiratory, cardiovascular, neuromuscular, and cognitive function. The 6MWT does not differentiate what limits the patient nor does it assess maximal exercise capacity. Instead, the 6MWT allows the patient to exercise at a daily functional level and is a useful tool for assessing severity of disease, and increasing walk distance correlates with a subjective improvement in dyspnea
Blood Pressure Measurements (SBP & DBP)
Time frame: Baseline; 6th Week; 12th Week
An appropriately sized cuff for the arm circumference was installed on the non-dominant arm. Blood pressure was measured every 20 minutes by 24 hours, and awake and sleep periods were determined according to information provided by the patients, the following are 7 strategies recommended by the AHA/AMA for accurate attainment of BP: 1) no conversation, 2) empty bladder, 3) use correct cuff size, 4) place BP cuff on bare arm, 5) support arm at heart level, 6) keep legs uncrossed, and 7) support back and feet
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 19 Apr 2024.
- Background: PubMed 28549665Shaltout HA, Eggebeen J, Marsh AP, Brubaker PH, Laurienti PJ, Burdette JH, Basu S, Morgan A, Dos Santos PC, Norris JL, Morgan TM, Miller GD, Rejeski WJ, Hawfield AT, Diz DI, Becton JT, Kim-Shapiro DB, Kitzman DW. Effects of supervised exercise and dietary nitrate in older adults with controlled hypertension and/or heart failure with preserved ejection fraction. Nitric Oxide. 2017 Sep 30;69:78-90. doi: 10.1016/j.niox.2017.05.005. Epub 2017 May 23.
- Background: PubMed 34911289Lebedeva OD, Achilov AA, Mavlyanova ZF, Baranov AV, Achilova SA, Sanina NP, Fesyun AD, Rachin AP, Yakovlev MY, Terentev KV, Reverchuk IV, Velilyaeva AS, Maccarone MC, Masiero S. Is relaxation exercise therapy effective in the management of patients with severe arterial hypertension? Eur J Transl Myol. 2021 Dec 15;31(4):10327. doi: 10.4081/ejtm.2021.10327.
- Background: PubMed 25436830Su TT, Majid HA, Nahar AM, Azizan NA, Hairi FM, Thangiah N, Dahlui M, Bulgiba A, Murray LJ. The effectiveness of a life style modification and peer support home blood pressure monitoring in control of hypertension: protocol for a cluster randomized controlled trial. BMC Public Health. 2014;14 Suppl 3(Suppl 3):S4. doi: 10.1186/1471-2458-14-S3-S4. Epub 2014 Nov 24.
- Background: PubMed 36993009Kundapur R, Modi B, Mary L, Manjula R, Santhosh P, Saxena D. A community-level educational intervention trail to study the impact of life style modification in control of hypertension and diabetes- A non-randomized trial (Before and after intervention study without control). J Family Med Prim Care. 2022 Nov;11(11):6759-6764. doi: 10.4103/jfmpc.jfmpc_2174_21. Epub 2022 Dec 16.
- Background: PubMed 32024888Cherfan M, Vallee A, Kab S, Salameh P, Goldberg M, Zins M, Blacher J. Unhealthy behaviors and risk of uncontrolled hypertension among treated individuals-The CONSTANCES population-based study. Sci Rep. 2020 Feb 5;10(1):1925. doi: 10.1038/s41598-020-58685-1.
- 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.
Danish Hassan, PhD* 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 Relaxation Breathing Exercises 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 7 inclusion and 7 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 19 Apr 2024. 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?
6-minute walk test (6MWT) (time frame: Baseline; 6th Week; 12th Week). The study lists 2 primary outcomes in all. 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 NCT06131528, which also lists 5 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 19 Apr 2024.