Use of Cooling Vests in MS: Trial Design Without Results

study phaseThe objectives of this study are:\n\n* 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.\n* 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.\n* to investigate the effects of the three-week inpatient rehabilitation on the cardiorespiratory fitness, muscle strength and trait fatigue in persons with Multiple Sclerosis.\n\nResearchers 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.\n\nParticipants will\n\n* Wear a cooling vest during intensive active training sessions for one week\n* Attend the assessment appointments during study participation\n* Keep a diary recording their use of a cooling vest during intensive active training sessions",

sample sizeIn addition, the participants receive their usual multidisciplinary inpatient rehabilitation program.\n\nControl period:\n\nThe control period consists of the multidisciplinary inpatient rehabilitation program without cooling during intensive active training sessions.\n\nMultidisciplinary inpatient rehabilitation:\n\nThe multidisciplinary inpatient rehabilitation program is tailored to the patients' individual needs and includes physiotherapy (flexibility, mobility, strength, endurance, balance, walking), occupational therapy (ability and adaptation training) and, occasionally, speech therapy, neuropsychological training and/or counselling by a physician or social worker.\n\nThere are six measurement timepoints in this study:\n\n* T-1: endpoint assessment at baseline (pre-intervention/control (clinic entry))\n* T0: baseline endpoint assessment 1st week of intervention/control\n* T1: endpoint assessment after week 1 of intervention/control\n* T2: baseline endpoint assessment 2nd week of intervention/control\n* T3: endpoint assessment after week 2 of intervention/control\n* T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)\n\nState fatigue (VAS score), walking capacity, functional lower extremity muscle strength, balance, and cognition will be measured at T0, T1, T2, and T3 to investigate the effect of cooling vs.

randomizedDuring the inpatient stay in the rehabilitation clinic Valens, included participants will be randomized into the following two groups: persons with Multiple Sclerosis will either perform 1) first one week of cooling during intensive active training sessions followed by one week of no cooling during intensive active training sessions, or 2) first one week of no cooling during intensive active training sessions followed by one week of cooling during intensive active training sessions.

interventionParticipants will wear a cooling vest (Inuteq PCM CoolOver 6.5C) on their torso, that, according to the manufacturer's specifications, offers constant cooling for up to 1.5 hours at 6.5 degrees Celsius.

comparatorIn addition, the participants receive their usual multidisciplinary inpatient rehabilitation program.\n\nControl period:\n\nThe control period consists of the multidisciplinary inpatient rehabilitation program without cooling during intensive active training sessions.\n\nMultidisciplinary inpatient rehabilitation:\n\nThe multidisciplinary inpatient rehabilitation program is tailored to the patients' individual needs and includes physiotherapy (flexibility, mobility, strength, endurance, balance, walking), occupational therapy (ability and adaptation training) and, occasionally, speech therapy, neuropsychological training and/or counselling by a physician or social worker.\n\nThere are six measurement timepoints in this study:\n\n* T-1: endpoint assessment at baseline (pre-intervention/control (clinic entry))\n* T0: baseline endpoint assessment 1st week of intervention/control\n* T1: endpoint assessment after week 1 of intervention/control\n* T2: baseline endpoint assessment 2nd week of intervention/control\n* T3: endpoint assessment after week 2 of intervention/control\n* T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)\n\nState fatigue (VAS score), walking capacity, functional lower extremity muscle strength, balance, and cognition will be measured at T0, T1, T2, and T3 to investigate the effect of cooling vs.

primary endpointIn addition, the participants receive their usual multidisciplinary inpatient rehabilitation program.\n\nControl period:\n\nThe control period consists of the multidisciplinary inpatient rehabilitation program without cooling during intensive active training sessions.\n\nMultidisciplinary inpatient rehabilitation:\n\nThe multidisciplinary inpatient rehabilitation program is tailored to the patients' individual needs and includes physiotherapy (flexibility, mobility, strength, endurance, balance, walking), occupational therapy (ability and adaptation training) and, occasionally, speech therapy, neuropsychological training and/or counselling by a physician or social worker.\n\nThere are six measurement timepoints in this study:\n\n* T-1: endpoint assessment at baseline (pre-intervention/control (clinic entry))\n* T0: baseline endpoint assessment 1st week of intervention/control\n* T1: endpoint assessment after week 1 of intervention/control\n* T2: baseline endpoint assessment 2nd week of intervention/control\n* T3: endpoint assessment after week 2 of intervention/control\n* T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)\n\nState fatigue (VAS score), walking capacity, functional lower extremity muscle strength, balance, and cognition will be measured at T0, T1, T2, and T3 to investigate the effect of cooling vs.

findingsThe objectives of this study are:\n\n* 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.\n* 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.\n* to investigate the effects of the three-week inpatient rehabilitation on the cardiorespiratory fitness, muscle strength and trait fatigue in persons with Multiple Sclerosis.\n\nResearchers 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.\n\nParticipants will\n\n* Wear a cooling vest during intensive active training sessions for one week\n* Attend the assessment appointments during study participation\n* Keep a diary recording their use of a cooling vest during intensive active training sessions",

limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.