[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658404":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":91,"studyPopulation":87,"armGroups":92,"interventions":104,"overallOfficials":87,"centralContacts":112,"locations":122,"responsibleParty":137,"collaborators":87,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":87,"enrollmentInfo":151,"targetDuration":87,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":125,"whyStopped":87,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Klinik Valens","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"State Fatigue","State fatigue is measured using a visual analogue scale (VAS) score. The VAS comprises a 10-cm line ranging from \"not fatigued at all\" on the left end to \"the most fatigue imaginable\" on the right end. The respondent is asked to place a tick mark on the line to indicate the level of fatigue at that instant in time. The score, which corresponds to the distance from the left end of the scale to the tick mark, indicates the state level of fatigue.","T0: baseline endpoint assessment 1st week of intervention\u002Fcontrol T1: endpoint assessment after week 1 of intervention\u002Fcontrol T2: baseline endpoint assessment 2nd week of intervention\u002Fcontrol T3: endpoint assessment after week 2 of intervention\u002Fcontrol",[14,17,20,23,26,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":12},"Walking capacity","The Six-Minute Walk Test (6-MWT) is used to determine the total distance in meters covered within six minutes when walking back and forth on a 20-metres hallway, as a measure of endurance walking capacity. Participants are asked to walk back and forth at maximal walking speed for the duration of six minutes. The instruction is standardized as \"to walk at fastest speed, and to cover as much distance as possible\". Participants are allowed to use a walking aid, if necessary to ensure safe ambulation.",{"measure":18,"description":19,"timeFrame":12},"Functional lower extremity muscle strength","The five-time sit to stand (5STS) test measures the time needed for a person to stand up from a chair and sit back down five times as fast as possible.",{"measure":21,"description":22,"timeFrame":12},"Balance","The Mini-Balance Evaluation Systems Test (Mini-BESTest) measures the balance capacity of an individual and differentiates between four areas of balance: anticipatory, reactive postural control, sensory orientation and dynamical walking capacities. There are 14 different tasks. Each task will be scored from 0 to 2 points (0 = severe, 1 = moderate, 2 = normal) by the examiner. A maximal total score of 28 points can be achieved. Higher scores indicate better balance.",{"measure":24,"description":25,"timeFrame":12},"Cognition","Cognition is tested with the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), composed of the Symbol Digit Modalities Test (SDMT), the Verbal Learning and Memory Test (VLMT), and the Brief Visuospatial Memory Test (BVMT-R). The SDMT assesses processing speed. The test consists of single digits paired with abstract symbols. Rows of the nine symbols are arranged pseudo-randomly. The patient must say the number that corresponds with each symbol within 90 seconds. The VLMT assesses verbal memory. The VLMT comprises a 15-item word list. The list is read aloud five times in the same order to the patient. Patients are required to recall as many items as possible, in any order, after each reading of the list. The BVMT-R assesses visual memory. Participants inspect a 2 × 3 stimulus array of abstract geometric figures. There are three learning trials of 10s. The array is removed, and the participant is required to draw the array from memory.",{"measure":27,"description":28,"timeFrame":29},"Trait fatigue","Trait fatigue is assessed with the Fatigue Scale for Motor and Cognitive functions (FSMC), that allows separate rating of motor and cognitive fatigue, based on a 5-point Likert scale (range 1-5). Scores range from 20-100 for FSMC total score, and from 10-50 for each subscale (i.e. motor and cognitive). Higher scores indicate a higher level of fatigue. The instrument has defined cut-off scores to classify mildly, moderately, and severely fatigued patients. Cut-off for mild fatigue is set for the total score at 43 and for the motor and cognitive sub-scores at 22.","T-1: endpoint assessment at pre-intervention\u002Fcontrol (clinic entry) T4: endpoint assessment post-intervention\u002Fcontrol (3 weeks after clinic entry)",{"measure":31,"description":32,"timeFrame":29},"Muscle strength - upper extremity (row machine)","Muscle strength will be assessed using a five-repetition maximum (5RM) test. The test will be carried out on the seated row machine and will be measured in kilogram (kg). Firstly, the participants should warm up by completing several submaximal repetitions. Then, the 5RM will be determined within four trials with rest periods of 3 min between trials. An initial weight that is within the subject's perceived capacity (\\~ 50-70% of capacity) will be chosen. Thereafter, the resistance will be progressively increased by 2.5-20 kg until the subject is not able to complete the selected repetition(s). All repetitions should be performed at the same speed of movement and range of motion to ensure consistency between trials.",{"measure":34,"description":35,"timeFrame":29},"Muscle strength - lower extremity (leg press)","Muscle strength will be assessed using a five-repetition maximum (5RM) test. The test will be carried out on the leg press and will be measured in kilograms (kg). Firstly, the participants should warm up by completing several submaximal repetitions. Then, the 5RM will be determined within four trials with rest periods of 3 min between trials. An initial weight that is within the subject's perceived capacity (\\~ 50-70% of capacity) will be chosen. Thereafter, the resistance will be progressively increased by 2.5-20 kg until the subject is not able to complete the selected repetition(s). All repetitions should be performed at the same speed of movement and ran-ge of motion to ensure consistency between trials.",{"measure":37,"description":38,"timeFrame":29},"Cardiorespiratory fitness (peak oxygen consumption)","Peak oxygen consumption (VO2peak) in ml\u002Fmin and in ml\u002Fmin\u002Fkg will be assessed via following progressive cardiopulmonary exercise testing (CPET) on a cycle ergometer (Ergoline 800, Germany): The individual cardiorespiratory fitness level is monitored by direct and continuous measurements (breath by breath) of maximum oxygen consumption (VO2peak) by ergospirometry. The exercise ramp-type protocol consists of (a) a resting state measurement without pedalling while participants are sitting on the bicycle ergometer (2 minutes); (b) subsequent unloaded pedalling (20W) as a warm-up (3 minutes); (c) the testing phase until exhaustion, during which the workload is continuously increased by 5-10W every minute to ensure 8-12 minutes of testing; (d) followed by a cool-down of unloaded pedalling (20W, 3-5 minutes). HR and blood pressure are monitored every 2 minutes and for the last 10 seconds of the test. The rate of perceived exertion (RPE) is assessed via Borg-CR10 scale at phases (c) and (d).",{"measure":40,"description":41,"timeFrame":29},"Cardiorespiratory fitness (peak maximum power output)","Peak maximum power output will be assessed in watts via following progressive cardiopulmo-nary exercise testing (CPET) on a cycle ergometer (Ergoline 800, Germany): The individual car-diorespiratory fitness level is monitored by direct and continuous measurements (breath by breath) of maximum oxygen consumption (VO2peak) by ergospirometry. The exercise ramp-type protocol consists of (a) a resting state measurement without pedalling while participants are sitting on the bicycle ergometer (2 minutes); (b) subsequent unloaded pedalling (20W) as a warm-up (3 minutes); (c) the testing phase until exhaustion, during which the workload is con-tinuously increased by 5-10W every minute to ensure 8-12 minutes of testing; (d) followed by a cool-down of unloaded pedalling (20W, 3 - 5 minutes). HR and blood pressure are monitored every 2 minutes and for the last 10 seconds of the test. The rate of perceived exertion (RPE) is assessed via Borg-CR10 scale at phases (c) and (d).",{"measure":43,"description":44,"timeFrame":29},"Cardiorespiratory fitness (peak heartrate)","Peak heart rate will be assessed in beats per minutes via following progressive cardiopulmonary exercise testing (CPET) on a cycle ergometer (Ergoline 800, Germany): The individual cardiore-spiratory fitness level is monitored by direct and continuous measurements (breath by breath) of maximum oxygen consumption (VO2peak) by ergospirometry. The exercise ramp-type pro-tocol consists of (a) a resting state measurement without pedalling while participants are sit-ting on the bicycle ergometer (2 minutes); (b) subsequent unloaded pedalling (20W) as a warm-up (3 minutes); (c) the testing phase until exhaustion, during which the workload is continuous-ly increased by 5-10W every minute to ensure 8-12 minutes of testing; (d) followed by a cool-down of unloaded pedalling (20W, 3 - 5 minutes). HR and blood pressure are monitored every 2 minutes and for the last 10 seconds of the test. The rate of perceived exertion (RPE) is asses-sed via Borg-CR10 scale at phases (c) and (d).",[46,50,53,56,59,62,65,68,71,74,77,80],{"measure":47,"description":48,"timeFrame":49},"Sample characteristics - demographic data (age)","The age of the participants will be assessed in years.","At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention\u002Fcontrol (clinic entry)).",{"measure":51,"description":52,"timeFrame":49},"Sample characteristics - demographic data (sex)","The sex of the participants (female \u002F male \u002F diverse) will be recorded for the description of the study sample.",{"measure":54,"description":55,"timeFrame":49},"Sample characteristics - anthropometric data (height)","The participants' height will be recorded in meters.",{"measure":57,"description":58,"timeFrame":49},"Sample characteristics - anthropometric data (weight)","The weight of the participants will be assessed in kilograms.",{"measure":60,"description":61,"timeFrame":49},"Sample characteristics - anthropometric data (body mass index)","To describe the characteristics of the participants, the body mass index (BMI) is calculated by combining weight (in kg) and height (in m) in kg\u002Fm².",{"measure":63,"description":64,"timeFrame":49},"MS-related Data (phenotype)","For the description of the study sample, MS phenotype (Relapsing-Remitting MS (RRMS) \u002F Secondary Progressive MS (SPMS) \u002F Primary Progressive MS (PPMS)) will be assessed from medical records.",{"measure":66,"description":67,"timeFrame":49},"MS-related data (Expanded Disability Status Scale )","For the description of the study sample, Expanded Disability Status Scale (EDSS) will be assessed from medical records.",{"measure":69,"description":70,"timeFrame":49},"MS-related data (time since diagnosis)","For the description of the study sample, time since diagnosis will be assessed from medical records and reported in months.",{"measure":72,"description":73,"timeFrame":49},"MS-related data (disease modifying treatment)","For the description of the study sample, disease modifying treatments will be assessed from medical records and will recorded in the form of the drug name and the name of the active ingredient.",{"measure":75,"description":76,"timeFrame":49},"Use of medications","Participants' medication use will be assessed based on medical records and is listed by the name of the medication and the active ingredient.",{"measure":78,"description":79,"timeFrame":49},"Comorbid disorders","For the description of the study sample, participants' comorbid disorders will be assessed from medical records and will be listed by the name of the medication and the active ingredient.",{"measure":81,"description":82,"timeFrame":83},"Documentation of the use of the cooling vest during the cooling period","The following quantitative parameters will be assessed with the questionnaire\u002Fdiary: outdoor temperature, therapy during which the cooling vest was worn, time of day and duration for which the cooling vest was worn, reason for non-use, cooling effect, and clothing worn under the cooling vest.","Every day during the week of cooling",{"allocation":85,"interventionModel":86,"interventionModelDescription":87,"primaryPurpose":88,"observationalModel":87,"timePerspective":87,"maskingInfo":89},"RANDOMIZED","CROSSOVER",null,"TREATMENT",{"masking":90,"maskingDescription":87,"whoMasked":87},"NONE","This study has a prospective randomized controlled crossover trial design. During 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. There is a three-day washout period between the two periods\u002Fweeks.\n\nThis design was chosen to allow all participants to receive the intervention (i.e. the cooling vest during intensive active training sessions), and that each participant is his\u002Fher own control to minimize inter-individual variability.\n\nThe investigators hypothesize that one week of cooling during intensive active training sessions prevents an exercise-induced increase in state fatigue, compared to one week without cooling during the same intensive active training sessions, during the three-week inpatient rehabilitation stay in pwMS.\n\nExperimental period:\n\nThe experimental period consists of one week of wearing a cooling vest during intensive active training sessions during the inpatient rehabilitation stay. Participants 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. Participants are instructed to wear at least a (cotton) shirt under the cooling vest. 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, balance training), and physiotherapy (flexibility, mobility, strength, endurance, balance, walking). In 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\u002For 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\u002Fcontrol (clinic entry))\n* T0: baseline endpoint assessment 1st week of intervention\u002Fcontrol\n* T1: endpoint assessment after week 1 of intervention\u002Fcontrol\n* T2: baseline endpoint assessment 2nd week of intervention\u002Fcontrol\n* T3: endpoint assessment after week 2 of intervention\u002Fcontrol\n* T4: endpoint assessment post-intervention\u002Fcontrol (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. no cooling.\n\nAdditionally, cardiorespiratory fitness and muscle strength will be measured at T-1 and at T4 i) to determine the training intensity, and ii) to investigate the effect of the inpatient stay on cardiorespiratory fitness and muscle strength. Trait fatigue will additionally be measured with the Fatigue Scale for Motor and Cognitive Functions (FSMC) questionnaire at T-1 and at T4, because i) the FSMC total score is used as an inclusion criterion and as a stratification factor, and ii) to investigate the effect of the inpatient stay on trait fatigue.",[93,99],{"label":94,"type":95,"description":96,"interventionNames":97},"Intervention","EXPERIMENTAL","The experimental 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.",[98],"Other: Wearing a cooling vest during intensive, active training sessions",{"label":100,"type":6,"description":101,"interventionNames":102},"Control","The control period consists of the usual multidisciplinary inpatient rehabilitation program without cooling for one week.",[103],"Other: Control",[105,109],{"type":6,"name":106,"description":107,"armGroupLabels":108,"otherNames":87},"Wearing a cooling vest during intensive, active training sessions","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.",[94],{"type":6,"name":100,"description":110,"armGroupLabels":111,"otherNames":87},"The control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling.",[100],[113,118],{"name":114,"role":115,"phone":116,"phoneExt":87,"email":117},"Nadine Patt, M.Sc.","CONTACT","+41 58 511 13 83","nadine.patt@kliniken-valens.ch",{"name":119,"role":115,"phone":120,"phoneExt":87,"email":121},"Jens Bansi, Dr.","+41 58 511 13 02","jens.bansi@kliniken-valens.ch",[123],{"facility":124,"status":125,"city":126,"state":127,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":87},"Rehabilitation clinic Valens","RECRUITING","Valens","Canton of St. Gallen","7317","Switzerland","CH",{"type":132,"coordinates":133},"Point",[134,135],9.47705,46.96658,{"lat":135,"lon":134},{"type":138,"investigatorFullName":139,"investigatorTitle":140,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"PRINCIPAL_INVESTIGATOR","Nadine Patt","Research Associate","100658404","cooling-during-inpatient-rehabilitation-in-persons-with-ms-100658404",false,"NCT07852156","Cooling During Inpatient Rehabilitation in Persons With MS","Optimizing Inpatient Rehabilitation - Investigating the Effects of Cooling During Intensive Active Training Sessions on Fatigue in Persons With Multiple Sclerosis","CoolEx","Inclusion Criteria:\n\n* FSMC total score ≥ 43;\n* Adult age (≥ 18 years);\n* A definite MS diagnosis according to the 2024 revised McDonald criteria with relapsing-remitting, primary or secondary progressive phenotypes;\n* Disease severity according to Expanded disability status scale (EDSS) score 3.0-6.0;\n* Subjective perceived heat sensitivity (Yes).\n\nExclusion Criteria:\n\n* Inability to follow the study procedures (i.e. participant not fluent in oral and written German language);\n* Cognitive impairment (Montreal Cognitive Assessment, MoCA score \\\u003C 26);\n* 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;\n* Participation in another study;\n* Pregnant or lactating women;\n* Intention to become pregnant during this study;\n* Suspected non-compliance;\n* Previous enrolment into this study;\n* Sudden severe disease progression or falling sick (e.g. bacterial or viral infections) during the study;\n* Subjective perceived cold sensitivity (Yes).","ALL","18 Years",{"count":152,"type":153},42,"ESTIMATED","INTERVENTIONAL",[156],"NA","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:\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",[159,160,161],"Multiple Sclerosis","Heat Tolerance","Fatigue Symptom",[163,164,165,166],"cooling","exercise training","Multiple sclerosis","multidisciplinary rehabilitation","2026-09-25",{"date":169,"type":170},"2026-10-01","ACTUAL",{"date":172,"type":170},"2026-07-28",{"date":174,"type":153},"2028-09-30",{"name":5,"class":6},1]