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Trial registered on ANZCTR
Registration number
ACTRN12623001312639
Ethics application status
Approved
Date submitted
22/11/2023
Date registered
15/12/2023
Date last updated
25/04/2024
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Blood pressure response to differing modes of hot-water immersion in people with hypertension
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Scientific title
Blood pressure response to differing modes of hot-water immersion in people with hypertension
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Secondary ID [1]
311010
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
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Condition category
Condition code
Cardiovascular
328849
328849
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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
All participants will complete 3 water immersion sessions and a control session (in a randomised order): 1) 30-min whole-body hot-water immersion (40°C; chest depth), 2) 30-min waist deep hot-water immersion (40°C), 3) 30-min lower-limb hot-water immersion (~40°C; below knee depth).
There will be a 4-day washout between exposures.
1. 30-min whole-body hot-water immersion (40°C)
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the primary investigator (PI) or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min hot water immersion session in 40 °C water. Participants will be seated upright with water approximately nipple level.
Duration: 30 min.
2. 30-min waist-deep hot-water immersion (40°C)
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min hot water immersion session in 40 °C water. Participants will be seated upright with water approximately waist deep level.
Duration: 30 min.
3. 30-min lower-limb hot-water immersion (40°C)
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min hot water immersion session in 40 °C water. Participants will be seated upright with water approximately at below knee level.
Duration: 30 min.
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Intervention code [1]
327449
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Treatment: Other
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Comparator / control treatment
30-min control (no exposure).
Location: School of Physical Education, Sport and Exercise Sciences Aquatic Facility (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College of Sports Medicine (ACSM) registered clinical exercise physiologist (CEP), and the PI or a research assistant; all supervising researchers are first aid trained. Attendance and session particulars (e.g., physiological indices etc.) will be recorded at each session by the supervising researcher.
Exposure: Participants will complete a single 30-min resting session (i.e., no exposure/water immersion). Participants will be seated upright in a chair.
Duration: 30 min.
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Control group
Active
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Outcomes
Primary outcome [1]
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Blood pressure
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Assessment method [1]
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Assessed via ausculatory method (i.e., with sphygmomanometer and stethoscope) and ambulatory method (i.e., 24 hour blood pressure monitor).
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Timepoint [1]
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Pre-exposure, during exposure (every 10 mins), immediately post-completion of exposure and every hour across 24-h post-completion of exposure.
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Secondary outcome [1]
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Physical activity
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Assessment method [1]
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Assessed via accelerometry
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Timepoint [1]
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Across the 24-h post-completion of exposure
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Secondary outcome [2]
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Heart rate
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Assessment method [2]
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Assessed via chest strap
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Timepoint [2]
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Pre-exposure, during exposure (every 5 mins) and immediately post-completion of exposure.
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Eligibility
Key inclusion criteria
- Aged > 35 y or older;
- Prescribed and regularly taking at least one anti-hypertensive medication;
- Able to give written consent;
- Able to travel to the study centre to complete all sessions.
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Minimum age
35
Years
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Maximum age
85
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
- Aged < 35 y;
- Contraindication to maximal exercise testing;
- Unstable angina;
- Recent myocardial infarction (< 3 months ago);
- History of orthostatic intolerance/hypotension;
- Current pregnancy;
- New anti-hypertensive pharmaceutical initiated recently (i.e., > 30 days since initiation);
- Any other medical condition deemed a significant risk to study participation.
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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)
Allocation will not be concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
18/12/2023
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Actual
18/12/2023
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Date of last participant enrolment
Anticipated
20/12/2024
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
10
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Accrual to date
2
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Final
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Recruitment outside Australia
Country [1]
25982
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New Zealand
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State/province [1]
25982
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Otago
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Address [1]
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PO Box 56 Dunedin 9054 New Zealand
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
PO Box 56 Dunedin 9054 New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
317311
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Country [1]
317311
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Health and Disability Ethics Committee New Zealand
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Ethics committee address [1]
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PO Box 5013. Wellington 6140
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
314193
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11/10/2023
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Approval date [1]
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08/12/2023
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Ethics approval number [1]
314193
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2023/EXP/18988
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Summary
Brief summary
This 4x4 randomised crossover study will aim to recruit 10 participants taking at least one anti-hypertensive medication. Participants will complete 4 sessions: 1) 30-min whole-body (chest deep) hot-water immersion (40°C), 2) 30-min waist deep hot-water immersion (40°C), 3) 30-min lower-limb hot-water immersion (below knee depth deep in 40°C), and 4) 30-min control (no exposure). Physiological measures will be taken during each exposure to characterise the stimulus (e.g., beat-to-beat blood pressure, heart rate). Following each exposure participants will be fitted with an ambulatory blood pressure monitor (and accelerometer to confirm standardisation of activity levels) for the following 24 h to quantify the magnitude and duration of post-session hypotension.
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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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Dr Brendon Roxburgh
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Address
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Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
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Country
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New Zealand
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Phone
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+64 274632376
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Fax
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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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Dr Brendon Roxburgh
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Address
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Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
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Country
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New Zealand
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Phone
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+64 274632376
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Fax
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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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Dr Brendon Roxburgh
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Address
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Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
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Country
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New Zealand
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Phone
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+64 274632376
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Fax
130744
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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)?
No
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No/undecided IPD sharing reason/comment
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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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