HypertensionNCT02752217
Effectiveness of Inspiratory Muscle Training With Slow Breathing in Elderly With ISH
A study testing Inspiratory Muscle Training in people with Hypertension, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2016to Sep 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 60 to 80 years of age with an essential isolated systolic hypertension stage I II based on recommendation of JNC VII from primary care units in community and the Outpatient Department of Srinakarind hospital in Khon Kaen province Thailand
- Good communication and co operation
- Independent physical activity
- Stable controlled hypertension
Who cannot join
- Essential isolated systolic hypertension stage III or secondary hypertension
- History of heart disease such as coronary artery disease myocardial infarction
- History of respiratory disease such as asthma chronic bronchitis
- History of neuromuscular disease such as muscle weakness cerebrovascular disease
- History of renal disease
- Exercise limited by pain
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Associated Medical Sciences
Na Muang, Changwat Khon Kaen, 40002
Phailin Tongdee, Master, 0862957922, pang_haru@hotmail.com
Chulee Jones, Docter, 0845164169, joneschulee@gmail.com
About this study
Official title: Effectiveness of Inspiratory Muscle Training With Antihypertensive Breathing Technique on Lung and Exercise Capacity in Elderly With Isolated Systolic Hypertension
Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension.
Read the detailed description
Study the effects of inspiratory muscle training at Low load of 25 % Maximal inspiratory pressure with slow breathing rate at 6 breaths/min with BreatheMAXยฎdevice for 8 weeks at home on inspiratory muscle strength, lung function (slow vital capacity, inspiratory capacity), chest wall expansion, abdominal expansion, exercise capacity by arm ergometry and blood pressure in elderly with Isolated systolic hypertension. who have age 60-80 years.
- Conditions
- Hypertension
- Being tested
- Inspiratory Muscle Training, Control
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
ControlOther
Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Subjects in the inspiratory muscle training (IMT) group will perform loaded deep breathing exercise at 6 breaths/min using BreatheMaxยฎ device. The IMT protocol at 6 breathing rate (inspiratory time = 4 seconds and expiratory time = 6 seconds) with load at 25 percent of MIP for eighth weeks.
The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks Receives: Other: Inspiratory Muscle Training |
| Control | Placebo comparator | Subjects in the control (CON) group will perform breathing exercise with inspiratory load at 2 cmH2O at 6 breathing rate using one BreatheMAXยฎ device. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Maximal inspiratory pressure (MIP)
MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent)
Measured: Baseline and at 8 weeks
Secondary outcomes (4)
Lung capacity
Lung capacity consists of slow vital capacity (SVC), inspiratory capacity (IC). SVC and IC will be measure by a portable computerized spirometer (KoKo spirometer)
Measured: Baseline and at 8 weeks
Exercise capacity
Exercise capacity by Arm ergometer consists of exercise times, rating of perceived breathlessness (RPB) will examined by Borg scale
Measured: Baseline and at 8 weeks
Chest wall expansion and abdominal expansion
chest wall expansion and abdominal expansion measured at xiphoid process level and middle between the ambrical and xiphiod process level by use a flexible measuring tape (cm)
Measured: Baseline and at 8 weeks
Blood pressure (BP)
Blood pressure (BP) at home measured by digital bedside monitor. Accordingly follow ACMS recommended. And BP at laboratory test measured by Bedside monitor.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phailin Tongdee, Khon Kaen University
- Investigators
- Phailin Tongdee, Master, Principal investigator, Faculty of Associated Medical Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752217
- Sponsor's protocol ID
- HE 581469
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 20795924Ublosakka-Jones C, Tongdee P, Pachirat O, Jones DA. Slow loaded breathing training improves blood pressure, lung capacity and arm exercise endurance for older people with treated and stable isolated systolic hypertension. Exp Gerontol. 2018 Jul 15;108:48-53. doi: 10.1016/j.exger.2018.03.023. Epub 2018 Mar 28.
PubMed 29604403
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inspiratory Muscle Training With Antihypertensive Breathing Technique on Lung and Exercise Capacity in Elderly With Isolated Systolic Hypertension
- ClinicalTrials.gov ID
- NCT02752217
- Acronym / sponsor ID
- HE 581469
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Apr 2016 (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.
Study the effects of inspiratory muscle training at Low load of 25 %Maximal inspiratory pressure with slow breathing rate at 6 breaths/min on inspiratory muscle strength, lung function, chest wall expansion, abdominal expansion, exercise capacity and blood pressure in elderly with Isolated systolic hypertension.
Detailed description
Study the effects of inspiratory muscle training at Low load of 25 % Maximal inspiratory pressure with slow breathing rate at 6 breaths/min with BreatheMAXยฎdevice for 8 weeks at home on inspiratory muscle strength, lung function (slow vital capacity, inspiratory capacity), chest wall expansion, abdominal expansion, exercise capacity by arm ergometry and blood pressure in elderly with Isolated systolic hypertension. who have age 60-80 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | Other: Inspiratory Muscle TrainingSubjects in the inspiratory muscle training (IMT) group will perform loaded deep breathing exercise at 6 breaths/min using BreatheMaxยฎ device. The IMT protocol at 6 breathing rate (inspiratory time = 4 seconds and expiratory time = 6 seconds) with load at 25 percent of MIP for eighth weeks. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks |
| Control | Placebo comparator | Other: ControlSubjects in the control (CON) group will perform breathing exercise with inspiratory load at 2 cmH2O at 6 breathing rate using one BreatheMAXยฎ device. The pressure will be control by pressure manometer and duty cycle are control by subjects count duration for inspiration and expiration during training. The program will perform at home for 10 breaths/min/set, 6 sets/day with at least 1 minutes rest between sessions, 7 days/week for 8 weeks |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 60 to 80 years of age with an essential isolated systolic hypertension stage I II based on recommendation of JNC VII from primary care units in community and the Outpatient Department of Srinakarind hospital in Khon Kaen province Thailand
- Good communication and co operation
- Independent physical activity
- Stable controlled hypertension
Key exclusion criteria (6 listed)
- Essential isolated systolic hypertension stage III or secondary hypertension
- History of heart disease such as coronary artery disease myocardial infarction
- History of respiratory disease such as asthma chronic bronchitis
- History of neuromuscular disease such as muscle weakness cerebrovascular disease
- History of renal 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 |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home | Other | Inspiratory Muscle Training (IMT) |
| ControlInspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home | Other | Control |
Primary outcome
Change from baseline in Maximal inspiratory pressure (MIP)
Time frame: Baseline and at 8 weeks
MIP will be measure by Mouth pressure meter (Micro RPM, Micro Medical, Inc., Chatham Maritime, Kent)
4 secondary outcomes
Lung capacity
Time frame: Baseline and at 8 weeks
Exercise capacity
Time frame: Baseline and at 8 weeks
Chest wall expansion and abdominal expansion
Time frame: Baseline and at 8 weeks
Blood pressure (BP)
Time frame: Baseline and at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 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.
- Derived from this study: PubMed 29604403Ublosakka-Jones C, Tongdee P, Pachirat O, Jones DA. Slow loaded breathing training improves blood pressure, lung capacity and arm exercise endurance for older people with treated and stable isolated systolic hypertension. Exp Gerontol. 2018 Jul 15;108:48-53. doi: 10.1016/j.exger.2018.03.023. Epub 2018 Mar 28.
- An inspiratory load enhances the antihypertensive effects of home-based training with slow deep breathing: a randomised trial.Link provided by the sponsor.
- 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.
Phailin Tongdee, Master principal investigator
Faculty of Associated Medical Sciences.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Apr 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phailin Tongdee, Master (0862957922, pang_haru@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Maximal inspiratory pressure (MIP) (time frame: Baseline and at 8 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 NCT02752217, which also lists 2 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 26 Apr 2016.