Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12624000814572
Ethics application status
Approved
Date submitted
18/06/2024
Date registered
2/07/2024
Date last updated
2/07/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Hot-water immersion or exercise training for hauora in people with hypertension
Query!
Scientific title
Hot-water immersion or exercise training for health and well-being (hauora) in people with hypertension
Query!
Secondary ID [1]
312233
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hypertension
333973
0
Query!
Condition category
Condition code
Cardiovascular
330641
330641
0
0
Query!
Hypertension
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants will be randomised to either 3 sessions per week of hot-water immersion in 40°C water or high-intensity interval training, for 8 weeks.
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 Sports Medicine (ACSM) registered clinical exercise physiologist (CEP) and 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 three hot-water immersion sessions per week in 40°C water. Participants will be seated (or semi-recumbent) with water approximately top-sternal level.
Duration: Bathing duration will progressively increase from 20 to 30 min if tolerable (20 min first week, 25 min second week and 30 min third and subsequent weeks).
Query!
Intervention code [1]
328715
0
Treatment: Other
Query!
Comparator / control treatment
High-intensity interval training (HIIT)
Location: School of Physical Education Sport and Exercise Sciences Exercise Clinic (University of Otago, Dunedin).
Supervision: This session will be supervised by an American College Sports Medicine (ACSM) registered clinical exercise physiologist (CEP) and 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: HIIT will be performed 3 times a week using a cross-trainer, arm ergometer or cycle (participant preference). Each session will begin with a 5-min warm-up on an exercise modality of the participants choosing. Initial sessions will begin with 6 x 60 s intervals, with recovery (90 s) in between intervals. Interval duration will remain constant throughout the intervention, with the aim of increasing the number of intervals to 8 and recovery duration decreasing to 60 s, Exercise intensity will initially be set at 85% of each participants VO2peak, before increasing each interval until a score of 7/10 on the rating of perceived exertion (RPE) scale is achieved; this corresponding workload will be used for subsequent intervals. As fitness increases, workload will increase to maintain this RPE,. Each session will last ~15 min and include a cool-down with light-intensity, whole-body flexibility exercise.
Duration: Participants will complete 8 weeks of HIIT.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338389
0
Change in mean 24-hour resting blood pressure.
Query!
Assessment method [1]
338389
0
24-hour ambulatory blood pressure monitor.
Query!
Timepoint [1]
338389
0
Baseline (pre-intervention) and 24-hours post-intervention. Ambulatory blood pressure will also be measured immediately after the first sessions in week one and four of the intervention.
Query!
Secondary outcome [1]
435905
0
Physical Function
Query!
Assessment method [1]
435905
0
Timed up-and-go test: The participant is seated on a chair 43 cm high (without arm rests) and a cone is placed 3 m directly in front of the chair. On the command, “go”, the timer starts, and participants will stand and then walk as quickly as possible around the cone and return to the chair; the timer stops when the participant is seated. The test is completed without the use of walking aids and the tester immediately nearby to assist if necessary.
30-second sit-to-stand test: The 30-second sit-to-stand test will be performed using a 43 cm chair (without arm rests) placed against a wall or firm surface. Following a practice, the tester will ask the participant to complete as many sit-to-stands as possible without using their arms, in a 30-s period. The score is the total number of correctly executed stands within the 30 s. If the participant is more than halfway up when the time expires, the move will count as a full repetition.
Query!
Timepoint [1]
435905
0
Baseline (pre-intervention) and 24-hours post-intervention.
Query!
Secondary outcome [2]
435906
0
Resting blood pressure.
Query!
Assessment method [2]
435906
0
Assessed via auscultatory method (using stethoscope and sphygmomanometer).
Query!
Timepoint [2]
435906
0
Baseline (pre-intervention), during and immediately post each session, and 24-hours post-intervention.
Query!
Secondary outcome [3]
435910
0
Heart rate
Query!
Assessment method [3]
435910
0
Chest Strap heart rate monitor
Query!
Timepoint [3]
435910
0
Baseline (pre-intervention), immediately before, during and after each session and 24-hours post-intervention.
Query!
Secondary outcome [4]
435915
0
Plasma Volume
Query!
Assessment method [4]
435915
0
A 5 mL blood sample will be obtained via a finger prick. Whole blood collected will be collected in triplicate via capillary tube and then centrifuged for 10-min at 855g to measure haematocrit to calculate changes in plasma volume.
Query!
Timepoint [4]
435915
0
Before and 24-hours after intervention sessions one and six only.
Query!
Secondary outcome [5]
435919
0
Quality of life
Query!
Assessment method [5]
435919
0
12-item short-form health survey (SF-12).
Query!
Timepoint [5]
435919
0
Baseline (pre-intervention) and 24-hours post-intervention.
Query!
Secondary outcome [6]
435920
0
7 day physical activity levels
Query!
Assessment method [6]
435920
0
Accelerometery
Query!
Timepoint [6]
435920
0
Baseline (pre-intervention) and 24-hours post-intervention.
Query!
Secondary outcome [7]
435921
0
Anaerobic threshold
Query!
Assessment method [7]
435921
0
Assessed via the collection of expired gasses [O2 & CO2] during cardiopulmonary exercise testing.
Query!
Timepoint [7]
435921
0
Baseline (pre-intervention) and 24-hours post-intervention.
Query!
Secondary outcome [8]
435925
0
Psychophysiological Status
Query!
Assessment method [8]
435925
0
Feeling Scale, thermal discomfort, thermal sensation, and rating of perceived exertion.
Query!
Timepoint [8]
435925
0
Baseline (pre-intervention), during each session, and 24-hours post-intervention.
Query!
Secondary outcome [9]
436450
0
Ventricular ectopic burden
Query!
Assessment method [9]
436450
0
Chest strap heart rate monitor
Query!
Timepoint [9]
436450
0
During session one and during the final session
Query!
Eligibility
Key inclusion criteria
- Aged 35 years or older;
- Prescribed and regularly taking at least one anti-hypertensive medication;
-Fulfils the Physical Activity Readiness Questionnaire Plus questionnaire criteria, or participant's physician provides medical clearance for study participation;
- Able to give written consent;
- Able to travel to the study centre to complete all sessions
Query!
Minimum age
35
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
-Aged less than 35 years;
-Contraindication to maximal exercise testing;
-Not "passing" the Physical Activity Readiness Questionnaire Plus questionnaire, and physician refuses medical clearance for study participation;
-Angina;
-Recent myocardial infarction (less than 3 months ago);
-Implanted cardiac device (i.e. ICD, pacemaker etc.);
-Heat intolerance;
-Current pregnancy;
-History of large blood pressure decreases or fainting;
-New anti-hypertensive pharmaceutical initiated recently (i.e., less than 30 days since initiation);
-Any other medical condition deemed a significant risk to study participation.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in an a sealed opaque envelope.
Query!
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).
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
8/07/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
7/03/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
2/05/2025
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26362
0
New Zealand
Query!
State/province [1]
26362
0
Dunedin
Query!
Funding & Sponsors
Funding source category [1]
316610
0
University
Query!
Name [1]
316610
0
University of Otago
Query!
Address [1]
316610
0
Query!
Country [1]
316610
0
New Zealand
Query!
Funding source category [2]
316757
0
Charities/Societies/Foundations
Query!
Name [2]
316757
0
Lottery Health Research
Query!
Address [2]
316757
0
Query!
Country [2]
316757
0
New Zealand
Query!
Primary sponsor type
University
Query!
Name
University of Otago
Query!
Address
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
318863
0
None
Query!
Name [1]
318863
0
Query!
Address [1]
318863
0
Query!
Country [1]
318863
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315396
0
University of Otago Human Ethics Committee (Health)
Query!
Ethics committee address [1]
315396
0
https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
Query!
Ethics committee country [1]
315396
0
New Zealand
Query!
Date submitted for ethics approval [1]
315396
0
13/05/2024
Query!
Approval date [1]
315396
0
24/05/2024
Query!
Ethics approval number [1]
315396
0
Query!
Summary
Brief summary
The purpose of this study is to evaluate the effectiveness of an 8-week hot-water immersion or high-intensity interval training (exercise) intervention on ambulatory blood pressure. This study aims to compare hot-water immersion or high-intensity interval training for improving ambulatory blood pressure in people with hypertension. It is hypothesised that 8-weeks of regular hot-water immersion exposure will improve ambulatory blood pressure to a greater extent than exercise.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
134570
0
Dr Brendon Roxburgh
Query!
Address
134570
0
School of Physical Education, Sport ad Exercise Sciences, 55 Union Street, Dunedin 9012, New Zealand
Query!
Country
134570
0
New Zealand
Query!
Phone
134570
0
+64 274632376
Query!
Fax
134570
0
Query!
Email
134570
0
[email protected]
Query!
Contact person for public queries
Name
134571
0
Brendon Roxburgh
Query!
Address
134571
0
School of Physical Education, Sport ad Exercise Sciences, 55 Union Street, Dunedin 9012, New Zealand
Query!
Country
134571
0
New Zealand
Query!
Phone
134571
0
+64 274632376
Query!
Fax
134571
0
Query!
Email
134571
0
[email protected]
Query!
Contact person for scientific queries
Name
134572
0
Brendon Roxburgh
Query!
Address
134572
0
School of Physical Education, Sport ad Exercise Sciences, 55 Union Street, Dunedin 9012, New Zealand
Query!
Country
134572
0
New Zealand
Query!
Phone
134572
0
+64 274632376
Query!
Fax
134572
0
Query!
Email
134572
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
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.
Download to PDF