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RECRUITING Not applicable ClinicalTrials.gov

Cooling During Inpatient Rehabilitation in Persons With MS

Sponsor: Klinik Valens • ClinicalTrials.gov ID: NCT07852156

Registry updated: 2026-10-01
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Description

The goal of this clinical trial is to shed light on the use of cooling during intensive active training sessions during a three-week multidisciplinary inpatient rehabilitation stay in persons with Multiple Sclerosis. The objectives of this study are: * to investigate the effects of one week of using a cooling vest during intensive active training sessions compared with one week of not using a cooling vest during inpatient rehabilitation on the state fatigue in persons with Multiple Sclerosis. * to investigate the effects of one week of using a cooling vest during intensive active training sessions compared with one week of not using a cooling vest during inpatient rehabilitation on the walking capacity, functional lower limb muscle strength, balance and cognition in persons with Multiple Sclerosis. * to investigate the effects of the three-week inpatient rehabilitation on the cardiorespiratory fitness, muscle strength and trait fatigue in persons with Multiple Sclerosis. Researchers will compare the effects of one week of using a cooling vest during intensive active training sessions with one week of not using a cooling vest during intensive active training sessions during three weeks of inpatient rehabilitation. Participants will * Wear a cooling vest during intensive active training sessions for one week * Attend the assessment appointments during study participation * Keep a diary recording their use of a cooling vest during intensive active training sessions

Interventions

  • Wearing a cooling vest during intensive, active training sessions (Other)
    The intervention period consists of one week of wearing a cooling vest during intensive active training sessions. The following rehabilitation prescriptions are defined as intensive active training sessions: endurance training (ergometer groups), resistance training (machine and bodyweight training), gait training (treadmill training), and physiotherapy (flexibility, mobility, strength, endurance, balance, walking). According to the manufacturer's specifications the cooling vest (Inuteq PCM CoolOver 6.5C) offers constant cooling for up to 1.5 hours at 6.5 degrees Celsius. In addition, the participants receive their usual multidisciplinary inpatient rehabilitation program.
  • Control (Other)
    The control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling.

Eligibility criteria

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).

Conditions

Multiple Sclerosis Heat Tolerance Fatigue Symptom

Locations

  • Rehabilitation clinic Valens — Valens, Canton of St. Gallen, Switzerland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record