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Trial registered on ANZCTR
Registration number
ACTRN12624000558527
Ethics application status
Approved
Date submitted
16/12/2023
Date registered
2/05/2024
Date last updated
2/05/2024
Date data sharing statement initially provided
2/05/2024
Date results provided
2/05/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of slow-loaded breathing training on resting blood pressure in essential hypertension Patients: A Randomized Controlled Trial
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Scientific title
Effects of slow-loaded breathing Training on home blood pressure and heart rate in essential hypertension Patients: A Randomized Controlled Trial
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Secondary ID [1]
311196
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None
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Universal Trial Number (UTN)
U1111-1301-7579
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Trial acronym
SLB (Slow loaded breathing)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
essential hypertension
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Condition category
Condition code
Physical Medicine / Rehabilitation
329085
329085
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0
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Physiotherapy
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Cardiovascular
329086
329086
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0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This intervention will be delivered by a physiotherapist. It involves slow breathing training using a minimal load of either 5 cmH2O or 7 cmH2O, which was set by the depth of water
in the bottle and controlled respiratory rate at 6 breaths per minute. The paced breathing was first practiced using metronome in the laboratory and create familiarity with training until patients comfortably while training at 1 week before starting the home training program. The training program was performed slow breathing training combine with minimal load at 5 cmH2O and 7 cmH2O at home for 30 minutes/session, 2 sessions/day with at least 30 minutes rest between sessions, every day for 8 weeks. Logbook used to assess or monitor adherence to the intervention. The training load of 5 cmH2O and 7 cmH2O were applied to separate groups of participants.
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Intervention code [1]
327644
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Rehabilitation
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Intervention code [2]
328174
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Treatment: Other
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Comparator / control treatment
Control (CON) group continued with normal daily activities.
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Control group
Active
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Outcomes
Primary outcome [1]
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Resting blood pressure this will be assessed as a composite outcome (SBP, DBP, PP and MAP)
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Assessment method [1]
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Resting blood pressure this will be assessed as a composite outcome (SBP, DBP, PP and MAP). All patients were used a digital upper arm blood pressure monitor (Microlife, BP 3BM1-3) with an appropriately sized cuff to measured home blood pressure: systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), and mean arterial pressure (MAP) in every morning before 9.00 am at sitting position after rest for least 15 minutes. Before the measurement patients were asked to refrain from caffeine or physical activity at least 30 minutes.
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Timepoint [1]
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Baseline and daily with average weekly measures assessed for each week of the intervention (8 weeks), final week averages will be primary timepoint
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Secondary outcome [1]
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Resting heart rate (HR)
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Assessment method [1]
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All patients were used a digital upper arm blood pressure monitor (Microlife, BP 3BM1-3) with an appropriately sized cuff to measured heart rate (HR) in every morning before 9.00 am at sitting position after rest for least 15 minutes. Before the measurement patients were asked to refrain from caffeine or physical activity at least 30 minutes.
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Timepoint [1]
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Baseline and daily for the length of the intervention (8 weeks)
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Eligibility
Key inclusion criteria
Inclusion criteria were subjects aged 30 to 59 years were I to II stage of essential hypertension, defined as average SBP 140-179 mmHg and DBP 90-109 mmHg based on recommendation of JNC-VII (Chobanian AV et al. 2007) with stable controlled hypertension before the study, good communication and co-operation.
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Minimum age
30
Years
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Maximum age
59
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria were secondary hypertension, use beta-blockers, heart disease (coronary artery disease, myocardial infarction, etc.), respiratory disease (asthma, chronic bronchitis), neuromuscular disease (muscle weakness, cerebrovascular disease, etc.), renal disease, metabolic syndrome, aortic aneurysm.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The outcomes of this study were the changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), pulse pressure (PP), and mean arterial pressure (MAP), which is an averaged value for each week from the daily data. Data were analyzed using repeated-measures ANOVA, followed by post hoc analysis with Bonferroni correction. All statistical analyses were performed using SPSS version 17.0 (SPSS, Ltd., Chicago, IL). Data are given as mean±SD, and mean changes with 95% Confidence Intervals. Significance is assumed at P=0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/12/2022
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Date of last participant enrolment
Anticipated
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Actual
18/07/2023
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Date of last data collection
Anticipated
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Actual
12/10/2023
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Sample size
Target
45
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Accrual to date
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Final
45
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Recruitment outside Australia
Country [1]
26040
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Thailand
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State/province [1]
26040
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Songkhla Province
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Funding & Sponsors
Funding source category [1]
315459
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University
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Name [1]
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Faculty of Medicine, Prince of Songkla University
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Address [1]
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15 Kanchanavanit Road, Hat Yai, Songkhla, 90110.
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Country [1]
315459
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Thailand
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Primary sponsor type
University
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Name
Faculty of Medicine, Prince of Songkla University
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Address
15 Kanchanavanit Road, Hat Yai, Songkhla, 90110
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Country
Thailand
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Secondary sponsor category [1]
318600
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None
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Name [1]
318600
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Address [1]
318600
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Country [1]
318600
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314367
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Human Research Ethics Committee Faculty of Medicine, Prince of Songkla University
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Ethics committee address [1]
314367
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15 Kanchanavanit Road, Hat Yai, Songkhla, 90110.
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Ethics committee country [1]
314367
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Thailand
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Date submitted for ethics approval [1]
314367
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14/11/2018
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Approval date [1]
314367
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01/02/2019
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Ethics approval number [1]
314367
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61-371-30-2
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Summary
Brief summary
To determine whether slow loaded breathing (SLB) training combine with minimal load at 5 cmH2O and 7 cmH2O has advantage of reducing resting home blood pressure and heart rate compared to normal daily activities in patient with essential hypertension. Materials and Methods: In this randomized controlled trial, forty-five patients with essential hypertension stage I or II. The training program was performed slow breathing training combine with minimal load at 5 cmH2O and 7 cmH2O at home for 30 minutes/session, 2 sessions/day with at least 30 minutes rest between sessions, every day for 8 weeks. Control (CON) group continued with normal daily activities. Measurement of resting blood pressure and heart rate at home and laboratory before and after the training on a daily basis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Phailin Thaworncheep
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Address
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Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
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Country
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Thailand
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Phone
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+66862957922
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Fax
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+6673-335130
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Email
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[email protected]
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Contact person for public queries
Name
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Phailin Thaworncheep
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Address
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Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
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Country
131327
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Thailand
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Phone
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+66862957922
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Fax
131327
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+6673-335130
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Email
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[email protected]
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Contact person for scientific queries
Name
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Phailin Thaworncheep
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Address
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Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
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Country
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Thailand
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Phone
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+66862957922
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Fax
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+6673-335130
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual participant data collected during the trial
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
any purpose
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How or where can data be obtained?
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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