Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001226897p
Ethics application status
Submitted, not yet approved
Date submitted
2/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new ice vest that could help people experiencing Multiple Sclerosis exercise
Scientific title
Effectiveness and acceptability of a novel cooling vest to assist people experiencing Multiple Sclerosis perform high-intensity exercise
Secondary ID [1] 304936 0
None
Universal Trial Number (UTN)
U1111-1268-4326
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heat sensitivity in Multiple Sclerosis 323087 0
Condition category
Condition code
Neurological 320661 320661 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two cooling vests with removable phase change cooling gel packs will be assessed separately including the UnderCool 2.0 (ThermApparel, Rochester, NY, USA) and the CryoVest Comfort (CryoInnov, Melesse, France). The vests will be individually fitted by the researcher and worn during 45 min of stationary cycling involving high-intensity intervals in a laboratory conditions of 22°C and 40% relative humidity. The exercise sessions will be supervised by an accredited physiotherapist or exercise scientist. The session is based on the 6th week/maintenance phase of the ‘MS Get A Head Start Program’ and includes;
•Warm-up: 2 min light-intensity, 2 min moderate-intensity, 1 min vigorous-intensity, 1 min rest (6 min total)
•Main set: 6 sets of 3 intervals (45 s high-intensity, 45 s rest) with 1 min rest between sets (33 min total)
•Cool-down: 6 min light-intensity (6 min total)
The intensities described above are established during a familiarisation session based on the Borg rating of perceived exertion scale.

The gel packs will be frozen according to manufacturer instructions and inserted into the vests immediately prior to commencing the exercise protocol. The UnderCool 2.0 weighs 0.6 kg with inserts and covers the abdomen and lower back. The CryoVest Comfort weighs 1.8 kg with inserts and covers the upper part of the torso from the collarbone to the upper abdomen and through to the mid-neck, posteriorly. In the control condition, no vest will be worn. Participants will wear standardised exercise clothing in all trials including a cotton t-shirt and polyester shorts. The cooling vests will be worn underneath the t-shirt. A control condition was chosen rather than a placebo (e.g. spraying the t-shirt with a liquid menthol solution), as the primary outcome measures of thermal and cardiovascular strain are objective measures that could not be influenced by a placebo effect.

Each participant will be subject to each intervention once in a randomised order involving a 2 h visit to the Research Centre each week for four weeks (familiarisation and then three experimental trials). Trials will be performed one-on-one or staggered in small groups of 2-3 people where possible and a checklist will be used to monitor attendance. The wash-out period between trials is one week.
Intervention code [1] 321331 0
Lifestyle
Intervention code [2] 321476 0
Treatment: Devices
Comparator / control treatment
CryoVest Comfort and no vest (control). Apart from the vest/no vest component itself, all other aspects of the session will be identical.
Control group
Active

Outcomes
Primary outcome [1] 328659 0
Gastrointestinal temperature with a temperature sensor pill ingested by participants prior to beginning each trial,
Timepoint [1] 328659 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise
Primary outcome [2] 328660 0
Mean skin temperature with infrared temperature scanner
Timepoint [2] 328660 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise
Primary outcome [3] 328661 0
total whole body sweat rate estimated from change in body mass measured by digital scales
Timepoint [3] 328661 0
measures of body mass collected before and after exercise to make calculation
Secondary outcome [1] 399854 0
Heart rate with chest band heart rate monitor
Timepoint [1] 399854 0
Every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise
Secondary outcome [2] 399855 0
thermal sensation with Young's thermal sensation scale
Timepoint [2] 399855 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics Survey software
Secondary outcome [3] 399856 0
Rating of perceived exertion using Borgs CR10 scale
Timepoint [3] 399856 0
Every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise
Secondary outcome [4] 399858 0
perceived pain using a custom 0-10 visual analogue scale where 0=none at all and 10=severe
Timepoint [4] 399858 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics survey software.
Secondary outcome [5] 399859 0
perceived urinary urgency using a custom 0-10 visual analogue scale where 0=none at all and 10=severe
Timepoint [5] 399859 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics survey software.
Secondary outcome [6] 399860 0
perceived concentration difficulty using a custom 0-10 visual analogue scale where 0=none at all and 10=severe
Timepoint [6] 399860 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics survey software.
Secondary outcome [7] 399861 0
perceived fatigue using a custom 0-10 visual analogue scale where 0=none at all and 10=severe
Timepoint [7] 399861 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics survey software.
Secondary outcome [8] 399862 0
vest concealability with a study specific single item question ("the vest was concealable") using a 1-7 Likert scale where 1=strongly disagree and 7=strongly agree.
Timepoint [8] 399862 0
upon completion of all exercise trials
Secondary outcome [9] 399863 0
vest comfort with a study specific single item question ("the vest was comfortable") using a 1-7 Likert scale where 1=strongly disagree and 7=strongly agree.
Timepoint [9] 399863 0
upon completion of all exercise trials
Secondary outcome [10] 399864 0
vest functionality with a study specific single item question ("the vest allowed me to move unrestricted") using a 1-7 Likert scale where 1=strongly disagree and 7=strongly agree.
Timepoint [10] 399864 0
at end of all exercise trials
Secondary outcome [11] 399865 0
'intention to use vest in future' with a study specific single item question ("I would use the vest during exercise if I had one") using a 1-7 Likert scale where 1=strongly disagree and 7=strongly agree.
Timepoint [11] 399865 0
at end of all exercise trials
Secondary outcome [12] 399866 0
thermal comfort with a study specific questionnaire of a 1-5 Likert scale where 1=comfortable and 5=extremely uncomfortable.
Timepoint [12] 399866 0
At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise. Measurements also taken at 2-, 4-, 6- and 8-hours post-exercise using Qualtrics survey software.

Eligibility
Key inclusion criteria
20 participants with a confirmed diagnosis of MS (including both relapsing remitting and primary progressive) will be recruited from within the ‘MS Get a Head Start’ exercise program in Coffs Harbour, NSW. Inclusion criteria are: aged between 18-64 years; report being 3-5.5 on the Expanded Disability Status Scale (EDSS); be at least 12 months from last relapse; completed at least 5-weeks of the ‘MS Get a Head Start Program’ including recumbent cycling; self-reported the presence of fatigue and heat-sensitivity as part of MS symptomology.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they are not cleared to perform high-intensity exercise as per the Exercise & Sports Science Australia Adult Pre-exercise Screening System and/or their general practitioner, or if they report any other condition that may affect thermoregulation (e.g. spinal cord injury, Parkinson disease). A need for analgesics or anti-inflammatory drugs within 72 hours of a trial will also be an exclusion criterion.

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 involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Counter-balanced
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was chosen based on a power calculation (G*Power 3.1.9.2) with an alpha of 0.05, an effect size of 0.25 and a power of 0.8. A conservative small effect size was chosen as cooling vests worn during exercise only have a small effect on the primary outcome variable of core body temperature.

For measures of body temperatures, sweat rate, heart rate, perceived exertion, thermal perception and heat related MS symptomology, a two-way repeated measures ANOVA (condition x time) will be used to determine if there is a statistically significant main or interaction effect. Where significant effects exist, paired-samples t-tests (with Holm-Bonferroni correction) will be used to determine significant differences between groups and time-points. For measures of vest acceptability, a Friedman test will be used to determine significant differences between distributions of the groups. Where significant differences in distributions exist, pairwise comparisons with Holm-Bonferroni correction (SPSS Statistics, 2012) will be conducted to determine significant differences between conditions. Cohen’s d effect size statistic will be calculated to determine the magnitude of any statistically significant differences and categorised as; 0.2 = small, 0.5 = medium and 0.8 = large effect.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/05/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34844 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 309320 0
University
Name [1] 309320 0
Southern Cross University
Country [1] 309320 0
Australia
Primary sponsor type
Individual
Name
Dr Christopher Stevens
Address
1 Hogbin Dr, Coffs Harbour, NSW 2450
Country
Australia
Secondary sponsor category [1] 310289 0
None
Name [1] 310289 0
Address [1] 310289 0
Country [1] 310289 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309144 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 309144 0
1 Military Dr, Lismore, NSW, 2480
Ethics committee country [1] 309144 0
Australia
Date submitted for ethics approval [1] 309144 0
12/08/2021
Approval date [1] 309144 0
Ethics approval number [1] 309144 0

Summary
Brief summary
To investigate the acute effect of the UnderCool 2.0 cooling vest during high-intensity exercise in a heat sensitive MS population on; i) body temperatures and sweating, ii) feelings of exertion and hotness, iii) MS symptoms that are aggravated by heat, and iv) Concealability, comfort and functionality.

With a controlled, cross-over design, 20 participants diagnosed with MS will complete four high-intensity interval cycling sessions on separate days including familiarisation and three experimental trials with participants wearing either; i) an UnderCool 2.0 cooling vest, ii) a CryoVest Comfort cooling vest (current evidence-informed practice), or iii) no vest. The exercise sessions will be high-intensity interval cycling sessions of 45 minutes in controlled conditions (22°C, 40% relative humidity). Exercise intensities will be standardised across all trials.

It is hypothesised that compared to control, during high-intensity exercise, the UnderCool 2.0 cooling vest will:
1) Attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate
2) Attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and
3) Reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency
It is further hypothesised that compared to the CryoVest Comfort, during high-intensity exercise, the UnderCool 2.0 cooling vest will:
4) Improve perceptions of concealability, comfort, functionality and intention to use
5) Similarly attenuate the increase in gastrointestinal temperature, mean skin temperature, sweat rate and heart rate
6) Similarly attenuate the increase in perceived exertion, thermal discomfort and thermal sensation, and
7) Similarly reduce perceptions of fatigue, pain, difficulty concentrating and urinary urgency
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113142 0
Dr Christopher Stevens
Address 113142 0
Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450
Country 113142 0
Australia
Phone 113142 0
+61 2 6659 8036
Fax 113142 0
Email 113142 0
[email protected]
Contact person for public queries
Name 113143 0
Dr Christopher Stevens
Address 113143 0
Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450
Country 113143 0
Australia
Phone 113143 0
+61 2 6659 8036
Fax 113143 0
Email 113143 0
[email protected]
Contact person for scientific queries
Name 113144 0
Dr Christopher Stevens
Address 113144 0
Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450
Country 113144 0
Australia
Phone 113144 0
+61 2 6659 8036
Fax 113144 0
Email 113144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Reduce risk of participant privacy invasion and to reduce the risk of poor secondary data analysis.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12739Ethical approval  [email protected]



Results publications and other study-related documents

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