Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001396516
Ethics application status
Approved
Date submitted
7/11/2024
Date registered
26/11/2024
Date last updated
26/11/2024
Date data sharing statement initially provided
26/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Does lower-leg hot-water immersion before or after exercise improve pain during and after exercise for people with osteoarthritis?
Scientific title
Does lower-leg hot-water immersion before or after exercise improve pain during and after exercise for people with osteoarthritis?
Secondary ID [1] 313302 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 335664 0
Condition category
Condition code
Musculoskeletal 332226 332226 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will complete 3 water immersion (40ºC) sessions and a control session (in a randomised order): 1) 15-min pre-exercise lower leg immersion + 30-min exercise; 2) 30-min exercise + 15-min post-exercise lower leg immersion; 3) 15-min pre-exercise lower leg immersion + 30-min exercise + 15-min post-exercise lower leg immersion; 4) 30-min exercise only (control)

There will be a 7-day washout between exposures.

1. 15-min pre-exercise lower leg immersion + 30-min exercise
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 15-min hot water immersion session in 40 °C water followed by 30-min moderate intensity walk on a treadmill or cycle (intensity assessed via Borg RPE scale), followed by 15-min seated rest (no water immersion).
Participants will be seated upright with water approximately below knee level.
Duration: 60 min.

2. 30-min exercise + 15-min post-exercise lower leg immersion
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 15-min seated rest (no water immersion), followed by a single 30-min moderate intensity walk on a treadmill or cycle (intensity assessed via Borg RPE scale), followed by a single 15-min hot water immersion session in 40 °C water.
Participants will be seated upright with water approximately below knee level. Duration: 60 min.

3. 15-min pre-exercise lower leg immersion + 30-min exercise + 15-min post-exercise lower leg immersion
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 15-min hot water immersion session in 40ºC water, followed by 30-min moderate intensity walk on a treadmill or cycle (intensity assessed via Borg RPE scale), followed by a single 15-min hot water immersion session in 40 °C water.
Participants will be seated upright with water approximately below knee level.
Duration: 60 min

Adherence will be assessed via direct observation.
Intervention code [1] 329890 0
Treatment: Other
Comparator / control treatment
30-min exercise (no hot water immersion)

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 15-min seated rest (no water immersion), followed by a single 30-min moderate intensity walk on a treadmill or cycle (intensity assessed via Borg RPE scale), followed by 15-min rest (no water immersion)
Participants will be seated upright in a chair.
Duration: 60 min.
Control group
Active

Outcomes
Primary outcome [1] 339800 0
Joint pain
Timepoint [1] 339800 0
Pre-exposure, every 5-10 min during exposure (i.e., immersion and exercise), immediately post-exposure, and then at 1 hr post-completion of exposure, 2 hr post-completion of exposure, 3 hr post-completion of exposure, before bed, upon waking and 1 hr after waking.
Secondary outcome [1] 441399 0
Physical activity
Timepoint [1] 441399 0
Across the 24-h post-completion of exposure.
Secondary outcome [2] 441412 0
Sleep
Timepoint [2] 441412 0
24 h following exposure
Secondary outcome [3] 441501 0
Blood pressure
Timepoint [3] 441501 0
Pre-exposure, during exposure (every 5-10 mins) and immediately post-completion of exposure.
Secondary outcome [4] 441502 0
Heart rate
Timepoint [4] 441502 0
Pre-exposure, during exposure (every 5-10 mins) and immediately post-completion of exposure.

Eligibility
Key inclusion criteria
- Has at least mild hip or knee osteoarthritis;
- Fulfils the Physical Activity Readiness Questionnaire Plus questionnaire criteria, or participant's physician provides medical clearance for study participation;
- Gives written consent;
- Able to travel to the study centre to complete all sessions.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not "passing" the Physical Activity Readiness Questionnaire Plus questionnaire, and physician refuses medical clearance for study participation;
- Angina;
- Recent myocardial infarction (< 3 months ago);
- Implanted cardiac device (i.e. ICD, pacemaker etc.);
- Heat intolerance;
- Pregnancy;
- Any other medical condition deemed a significant risk to study participation.

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)
Allocation will not be concealed
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 26677 0
New Zealand
State/province [1] 26677 0

Funding & Sponsors
Funding source category [1] 317751 0
Charities/Societies/Foundations
Name [1] 317751 0
Arthritis New Zealand
Country [1] 317751 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320070 0
None
Name [1] 320070 0
Address [1] 320070 0
Country [1] 320070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316438 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 316438 0
Ethics committee country [1] 316438 0
New Zealand
Date submitted for ethics approval [1] 316438 0
10/10/2024
Approval date [1] 316438 0
04/11/2024
Ethics approval number [1] 316438 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137898 0
Dr Brendon Roxburgh
Address 137898 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 137898 0
New Zealand
Phone 137898 0
+64274632376
Fax 137898 0
Email 137898 0
[email protected]
Contact person for public queries
Name 137899 0
Brendon Roxburgh
Address 137899 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 137899 0
New Zealand
Phone 137899 0
+64274632376
Fax 137899 0
Email 137899 0
[email protected]
Contact person for scientific queries
Name 137900 0
Brendon Roxburgh
Address 137900 0
Department of Surgical Sciences Level 4, Dunedin Public Hospital 201 Great King Street, Central Dunedin, Dunedin 9016
Country 137900 0
New Zealand
Phone 137900 0
+64274632376
Fax 137900 0
Email 137900 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.