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Recruiting NCT07852156

Cooling During Inpatient Rehabilitation in Persons With MS

Conditions: Multiple Sclerosis, Heat Tolerance, Fatigue Symptom

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: Klinik Valens

Location: Rehabilitation clinic Valens Valens Canton of St. Gallen

Summary

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

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).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07852156). StuddyBuddy aggregates publicly available trial information.