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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]

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

Condition category

Condition code

Neurological

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]

Lifestyle

Intervention code [2]

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]

Gastrointestinal temperature with a temperature sensor pill ingested by participants prior to beginning each trial,

Timepoint [1]

At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise

Primary outcome [2]

Mean skin temperature with infrared temperature scanner

Timepoint [2]

At baseline and every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise

Primary outcome [3]

total whole body sweat rate estimated from change in body mass measured by digital scales

Timepoint [3]

measures of body mass collected before and after exercise to make calculation

Secondary outcome [1]

Heart rate with chest band heart rate monitor

Timepoint [1]

Every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise

Secondary outcome [2]

thermal sensation with Young's thermal sensation scale

Timepoint [2]

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]

Rating of perceived exertion using Borgs CR10 scale

Timepoint [3]

Every 5 minutes throughout the trial. A mean will also be calculated for measures collected during exercise

Secondary outcome [4]

perceived pain using a custom 0-10 visual analogue scale where 0=none at all and 10=severe

Timepoint [4]

Secondary outcome [5]

perceived urinary urgency using a custom 0-10 visual analogue scale where 0=none at all and 10=severe

Timepoint [5]

Secondary outcome [6]

perceived concentration difficulty using a custom 0-10 visual analogue scale where 0=none at all and 10=severe

Timepoint [6]

Secondary outcome [7]

perceived fatigue using a custom 0-10 visual analogue scale where 0=none at all and 10=severe

Timepoint [7]

Secondary outcome [8]

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]

upon completion of all exercise trials

Secondary outcome [9]

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]

upon completion of all exercise trials

Secondary outcome [10]

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]

at end of all exercise trials

Secondary outcome [11]

'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]

at end of all exercise trials

Secondary outcome [12]

thermal comfort with a study specific questionnaire of a 1-5 Likert scale where 1=comfortable and 5=extremely uncomfortable.

Timepoint [12]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2450 - Coffs Harbour

Funding & Sponsors

Funding source category [1]

University

Name [1]

Southern Cross University

Address [1]

1 Hogbin Dr, Coffs Harbour, NSW 2450

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Christopher Stevens

Address

1 Hogbin Dr, Coffs Harbour, NSW 2450

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Southern Cross University Human Research Ethics Committee

Ethics committee address [1]

1 Military Dr, Lismore, NSW, 2480

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2021

Approval date [1]

Ethics approval number [1]

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

Dr Christopher Stevens

Address

Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450

Country

Australia

Phone

+61 2 6659 8036

Fax

christopher.stevens@scu.edu.au

Contact person for public queries

Name

Christopher Stevens

Address

Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450

Country

Australia

Phone

+61 2 6659 8036

Fax

christopher.stevens@scu.edu.au

Contact person for scientific queries

Name

Christopher Stevens

Address

Southern Cross University, 1 Hogbin Dr, Coffs Harbour, NSW, 2450

Country

Australia

Phone

+61 2 6659 8036

Fax

christopher.stevens@scu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
12739	Ethical approval			christopher.stevens@scu.edu.au

Results publications and other study-related documents

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