Trial Review

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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 information initially 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
Scientific title
Effects of slow-loaded breathing Training on home blood pressure and heart rate in essential hypertension Patients: A Randomized Controlled Trial
Secondary ID [1] 311196 0
None
Universal Trial Number (UTN)
U1111-1301-7579
Trial acronym
SLB (Slow loaded breathing)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
essential hypertension 332374 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329085 329085 0 0
Physiotherapy
Cardiovascular 329086 329086 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327644 0
Rehabilitation
Intervention code [2] 328174 0
Treatment: Other
Comparator / control treatment
Control (CON) group continued with normal daily activities.
Control group
Active

Outcomes
Primary outcome [1] 336903 0
Resting blood pressure this will be assessed as a composite outcome (SBP, DBP, PP and MAP)
Timepoint [1] 336903 0
Baseline and daily with average weekly measures assessed for each week of the intervention (8 weeks), final week averages will be primary timepoint
Secondary outcome [1] 430109 0
Resting heart rate (HR)
Timepoint [1] 430109 0
Baseline and daily for the length of the intervention (8 weeks)

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.
Minimum age
30 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
Actual
18/07/2023
Date of last data collection
Anticipated
Actual
12/10/2023
Sample size
Target
45
Accrual to date
Final
45
Recruitment outside Australia
Country [1] 26040 0
Thailand
State/province [1] 26040 0
Songkhla Province

Funding & Sponsors
Funding source category [1] 315459 0
University
Name [1] 315459 0
Faculty of Medicine, Prince of Songkla University
Country [1] 315459 0
Thailand
Primary sponsor type
University
Name
Faculty of Medicine, Prince of Songkla University
Address
15 Kanchanavanit Road, Hat Yai, Songkhla, 90110
Country
Thailand
Secondary sponsor category [1] 318600 0
None
Name [1] 318600 0
Address [1] 318600 0
Country [1] 318600 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314367 0
Human Research Ethics Committee Faculty of Medicine, Prince of Songkla University
Ethics committee address [1] 314367 0
15 Kanchanavanit Road, Hat Yai, Songkhla, 90110.
Ethics committee country [1] 314367 0
Thailand
Date submitted for ethics approval [1] 314367 0
14/11/2018
Approval date [1] 314367 0
01/02/2019
Ethics approval number [1] 314367 0
61-371-30-2

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131326 0
Mrs Phailin Thaworncheep
Address 131326 0
Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
Country 131326 0
Thailand
Phone 131326 0
+66862957922
Fax 131326 0
+6673-335130
Email 131326 0
phailin.t@psu.ac.th
Contact person for public queries
Name 131327 0
Mrs Phailin Thaworncheep
Address 131327 0
Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
Country 131327 0
Thailand
Phone 131327 0
+66862957922
Fax 131327 0
+6673-335130
Email 131327 0
phailin.t@psu.ac.th
Contact person for scientific queries
Name 131328 0
Mrs Phailin Thaworncheep
Address 131328 0
Department of Physical Therapy, Faculty of Medicine, Prince of Songkla University, Kho Hong, Hat Yai, Songkhla 90110
Country 131328 0
Thailand
Phone 131328 0
+66862957922
Fax 131328 0
+6673-335130
Email 131328 0
phailin.t@psu.ac.th

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
phailin.t@psu.ac.th


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.