Cooling During Inpatient Rehab for People with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this prospective randomized crossover study, adults with MS will undergo two one-week training periods during inpatient rehabilitation, contrasting sessions with a cooling vest vs. no cooling, separated by a short washout. Each participant acts as their own control to reduce variability. Outcomes include state fatigue, walking capacity, lower-limb strength, balance, cognition, cardiorespiratory fitness, and trait fatigue, measured across the three-week program. The intervention uses a cooling vest (Inuteq PCM CoolOver 6.5C) during intense active training sessions. The study aims to determine if cooling can mitigate exercise-related fatigue and enhance functional recovery in MS patients during multidisciplinary rehab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* FSMC total score ≥ 43;
* Adult age (≥ 18 years);
* A definite MS diagnosis according to the 2024 revised McDonald criteria with relapsing-remitting, primary or secondary progressive phenotypes;
* Disease severity according to Expanded disability status scale (EDSS) score 3.0-6.0;
* Subjective perceived heat sensitivity (Yes).

Exclusion Criteria:

* Inability to follow the study procedures (i.e. participant not fluent in oral and written German language);
* Cognitive impairment (Montreal Cognitive Assessment, MoCA score \< 26);
* Severe concomitant disease states (i.e. orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological disease states, other serious medical conditions) impairing the ability to participate;
* Participation in another study;
* Pregnant or lactating women;
* Intention to become pregnant during this study;
* Suspected non-compliance;
* Previous enrolment into this study;
* Sudden severe disease progression or falling sick (e.g. bacterial or viral infections) during the study;
* Subjective perceived cold sensitivity (Yes).

Where it's running

• Rehabilitation clinic Valens
  Valens, Canton of St. Gallen, Switzerland Recruiting

Study contacts

• Study coordinator: Nadine Patt, M.Sc.
• Email: nadine.patt@kliniken-valens.ch
• Phone: +41 58 511 13 83

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.