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Testing a new ice vest that could help people experiencing Multiple Sclerosis exercise

Effectiveness and acceptability of a novel cooling vest to assist people experiencing Multiple Sclerosis perform high-intensity exercise

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001226897
Enrollment
20
Registered
2021-09-13
Start date
2022-02-01
Completion date
2022-05-01
Last updated
2021-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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 scient

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.

Sponsors

Dr Christopher Stevens
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026