Systolic Essential HypertensionNCT02200926
Non-pharmacological Treatment for Essential Isolated Systolic Hypertension in Elderly
A study testing Loaded breathing training and Unloaded breathing training in people with Systolic Essential Hypertension, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The previous studies used the slow loaded breathing device for breathing training (Jones et al., 2010). It has been shown that slow loaded breathing training can reduce resting blood pressure and heart rate in essential hypertensive patients. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Systolic Essential Hypertension
- What is being tested?
- Loaded breathing training and Unloaded breathing training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2014to Sep 2016
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential isolated systolic hypertension (stage I- II, based on recommendations of JNC-VII)
- Good communication
Who cannot join
- Essential hypertension stage III or secondary hypertension
- History of respiratory disease, heart disease, renal disease, blindness, deafness and cerebrovascular disease.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of associated medical science, Khon Kaen University
Muang, Changwat Khon Kaen, 40000
About this study
Official title: Effects of Slow Loaded and Unloaded Breathing Training
The previous studies used the slow loaded breathing device for breathing training (Jones et al., 2010). It has been shown that slow loaded breathing training can reduce resting blood pressure and heart rate in essential hypertensive patients. However, this has not been studied in elderly with essential isolated systolic hypertensive patients. Not only highest prevalence of hypertension in Thailand was found in elderly but also physiological changes in the elderly are cause of interest in this special population. It has many advantages to use a slow loaded breathing training in elderly people. Firstly, it is low technology and easily implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded breathing training may be enhancing cardiopulmonary function and other fitness traits, but it out of scope of this study. Moreover, slow loaded breathing exercise by itself should not result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not been trained. If slow loaded breathing training modified some central component of the pressor reflex pathway in a way that single muscle training might work, as suggested above, then loaded breathing training would have a modulating effect on the pressor responses of muscles that had not been trained.
We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax on blood pressure at rest and exercise in elderly with essential isolated systolic hypertension and also investigate the autonomic function and others that may be involved with the changed blood pressure in elderly with essential isolated systolic hypertension. We hypothesized that slow loaded and unloaded breathing training could reduce resting and exercising blood pressure in elderly with essential isolated systolic hypertension.
Read the detailed description
All subjects will be trained for blood pressure and heart rate measurement at home by using a digital arm blood pressure monitoring for 2 weeks control periods before start breathing training. After 2 weeks, subjects in both breathing training groups will trained to inspire deeply against the resistance setting by using Breathmax at the loaded of 18 centimeter of water (cmH2O) and 0 cmH2O (no resistance) with breathing frequency control at 6 breaths/minute in loaded breathing (LB) and unloaded breathing (ULB) group, respectively. They will rest for 5 seconds after every 6 deep breathing. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The paced breathing will be practice using metronome at the laboratory until the subjects can do independently without metronome. The breathing was performed normally in control groups (C). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
After 8 weeks of breathing training, the sustainability of breathing training effect will be assessed. Subjects in both breathing training groups (LB and ULB) will be stop breathing training with Breathmax and change to breathing normally. In contrast with the subjects in control group, they will be divided to 2 subgroups. The first subgroup performed loaded breathing training at the loaded of 18 cmH2O. The another subgroup performed unloaded breathing training at the loaded of 0 cmH2O. Breathing frequency will be control at 6 breaths/minute in both subgroups. The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
Data collection will be carried out for 4 times: (1) before control, (2) before training, (3) after training and (4) after stop training. All measurement will be done in the cardiovascular laboratory room, department of physical therapy, faculty of associated medical sciences. In addition, self measurement of blood pressure and heart rate will be conducted at home every morning after getting up at the same time throughout the study (from week 0 to 18).
- Conditions
- Systolic Essential Hypertension
- Being tested
- Loaded breathing training, Unloaded breathing training, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loaded breathing trainingOther
7 days/weeks, for 8 weeks
Unloaded breathing trainingOther
7 days/week, for 8 weeks
PlaceboOther
7 days/week, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | The breathing was performed normally in this groups. Receives: Other: Placebo |
| Loaded breathing training | Experimental | subjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. Receives: Other: Loaded breathing training |
| Unloaded breathing training | Experimental | subjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. Receives: Other: Unloaded breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting blood pressure
Measured: 4 months
Secondary outcomes (7)
Heart rate
Measured: 4 months
Pulse wave velocity
Measured: 4 months
Exercise pressure response
Measured: 4 months
Heart rate variability
Measured: 4 months
cardiac output
Measured: 4 months
Flow-mediated dilatation of brachial artery
Measured: 4 months
Forearm limb blood flow
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjarat Sangthong, Khon Kaen University
- Investigators
- Benjarat Sangthong, M.Sc., Principal investigator, Faculty of associated medical science, Khon Kaen University, thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200926
- Sponsor's protocol ID
- BSangthong
- Other IDs
- change1me
- Status last verified
- Sep 2016
- First submitted
- 24 Jul 2014
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. doi: 10.1016/s1836-9553(10)70023-0.
PubMed 20795924
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slow Loaded and Unloaded Breathing Training
- ClinicalTrials.gov ID
- NCT02200926
- Acronym / sponsor ID
- BSangthong
- Conditions
- Systolic Essential Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Jul 2014 (estimated)
- 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 previous studies used the slow loaded breathing device for breathing training (Jones et al., 2010). It has been shown that slow loaded breathing training can reduce resting blood pressure and heart rate in essential hypertensive patients. However, this has not been studied in elderly with essential isolated systolic hypertensive patients. Not only highest prevalence of hypertension in Thailand was found in elderly but also physiological changes in the elderly are cause of interest in this special population. It has many advantages to use a slow loaded breathing training in elderly people. Firstly, it is low technology and easily implemented at home. Secondly, it can be practiced almost anytime and anywhere. Thirdly, the orthopedic complications of slow loaded breathing training are minimal. Finally, slow loaded breathing training may be enhancing cardiopulmonary function and other fitness traits, but it out of scope of this study. Moreover, slow loaded breathing exercise by itself should not result in any metabolic adaptation of skeletal muscles, such as the forearm, which had not been trained. If slow loaded breathing training modified some central component of the pressor reflex pathway in a way that single muscle training might work, as suggested above, then loaded breathing training would have a modulating effect on the pressor responses of muscles that had not been trained.
We, therefore, aim to study the effect of slow loaded breathing training by using Breathmax on blood pressure at rest and exercise in elderly with essential isolated systolic hypertension and also investigate the autonomic function and others that may be involved with the changed blood pressure in elderly with essential isolated systolic hypertension. We hypothesized that slow loaded and unloaded breathing training could reduce resting and exercising blood pressure in elderly with essential isolated systolic hypertension.
Detailed description
All subjects will be trained for blood pressure and heart rate measurement at home by using a digital arm blood pressure monitoring for 2 weeks control periods before start breathing training. After 2 weeks, subjects in both breathing training groups will trained to inspire deeply against the resistance setting by using Breathmax at the loaded of 18 centimeter of water (cmH2O) and 0 cmH2O (no resistance) with breathing frequency control at 6 breaths/minute in loaded breathing (LB) and unloaded breathing (ULB) group, respectively. They will rest for 5 seconds after every 6 deep breathing. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The paced breathing will be practice using metronome at the laboratory until the subjects can do independently without metronome. The breathing was performed normally in control groups (C). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
After 8 weeks of breathing training, the sustainability of breathing training effect will be assessed. Subjects in both breathing training groups (LB and ULB) will be stop breathing training with Breathmax and change to breathing normally. In contrast with the subjects in control group, they will be divided to 2 subgroups. The first subgroup performed loaded breathing training at the loaded of 18 cmH2O. The another subgroup performed unloaded breathing training at the loaded of 0 cmH2O. Breathing frequency will be control at 6 breaths/minute in both subgroups. The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks.
Data collection will be carried out for 4 times: (1) before control, (2) before training, (3) after training and (4) after stop training. All measurement will be done in the cardiovascular laboratory room, department of physical therapy, faculty of associated medical sciences. In addition, self measurement of blood pressure and heart rate will be conducted at home every morning after getting up at the same time throughout the study (from week 0 to 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: PlaceboThe breathing was performed normally in this groups. |
| Loaded breathing training | Experimental | Other: Loaded breathing trainingsubjects will trained to inspire deeply against the resistance setting by using BreathMAX® at the loaded of 18 cmH2O with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. |
| Unloaded breathing training | Experimental | Other: Unloaded breathing trainingsubjects will trained to inspire deeply (no resistance) with breathing frequency control at 6 breaths/minute. Breathing pattern will be controlled at duty cycle of 0.4 (inspiratory time = 4 sec and total respiratory time = 10 sec). The training program will be performed at home for 30 minutes/day, 7 days/week for 8 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Essential isolated systolic hypertension (stage I- II, based on recommendations of JNC-VII)
- Good communication
Key exclusion criteria (2 listed)
- Essential hypertension stage III or secondary hypertension
- History of respiratory disease, heart disease, renal disease, blindness, deafness and cerebrovascular disease.
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 |
|---|---|---|
| Loaded breathing training7 days/weeks, for 8 weeks | Other | Loaded breathing training |
| Unloaded breathing training7 days/week, for 8 weeks | Other | Unloaded breathing training |
| Placebo7 days/week, for 8 weeks | Other | Placebo |
Primary outcome
Resting blood pressure
Time frame: 4 months
7 secondary outcomes
Heart rate
Time frame: 4 months
Pulse wave velocity
Time frame: 4 months
Exercise pressure response
Time frame: 4 months
Heart rate variability
Time frame: 4 months
cardiac output
Time frame: 4 months
Flow-mediated dilatation of brachial artery
Time frame: 4 months
Forearm limb blood flow
Time frame: 4 months
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 12 Sep 2016.
- Results publication: PubMed 20795924Jones CU, Sangthong B, Pachirat O. An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial. J Physiother. 2010;56(3):179-86. doi: 10.1016/s1836-9553(10)70023-0.
- Individual participant dataSharing planned: Undecided
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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.
Benjarat Sangthong, M.Sc. principal investigator
Faculty of associated medical science, Khon Kaen University, thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loaded breathing training and Unloaded breathing training in people with Systolic Essential Hypertension, run by Khon Kaen University at 1 site in Thailand.
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 2 inclusion and 2 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 12 Sep 2016. 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 Thailand. 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?
Resting blood pressure (time frame: 4 months). 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 NCT02200926, which also lists 1 linked publication.
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 12 Sep 2016.