Multiple SclerosisCoolExNCT07852156
Cooling During Inpatient Rehabilitation in Persons With MS
A study testing Wearing a cooling vest during intensive, active training sessions in people with Multiple Sclerosis and Heat Tolerance, run by Klinik Valens at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Heat Tolerance, Fatigue Symptom
- What is being tested?
- Wearing a cooling vest during intensive, active training sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Jul 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Rehabilitation clinic Valens
Valens, Canton of St. Gallen, 7317
About this study
Official title: Optimizing Inpatient Rehabilitation - Investigating the Effects of Cooling During Intensive Active Training Sessions on Fatigue in Persons With Multiple Sclerosis
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.
Read more
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
Read the detailed description
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/weeks.
This 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/her own control to minimize inter-individual variability.
The 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.
Experimental period:
The 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.
Control period:
The control period consists of the multidisciplinary inpatient rehabilitation program without cooling during intensive active training sessions.
Multidisciplinary inpatient rehabilitation:
The 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.
There are six measurement timepoints in this study:
- T-1: endpoint assessment at baseline (pre-intervention/control (clinic entry))
- T0: baseline endpoint assessment 1st week of intervention/control
- T1: endpoint assessment after week 1 of intervention/control
- T2: baseline endpoint assessment 2nd week of intervention/control
- T3: endpoint assessment after week 2 of intervention/control
- T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
State 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.
Additionally, 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.
- Conditions
- Multiple Sclerosis, Heat Tolerance, Fatigue Symptom
- Being tested
- Wearing a cooling vest during intensive, active training sessions, Control
- Keywords
- cooling, exercise training, Multiple sclerosis, multidisciplinary rehabilitation
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing a cooling vest during intensive, active training sessionsOther
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.
ControlOther
The control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wearing a cooling vest during intensive, active training sessions |
| Control | Other | The control period consists of the usual multidisciplinary inpatient rehabilitation program without cooling for one week. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
Secondary outcomes (10)
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.
Measured: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
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.
Measured: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
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.
Measured: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
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.
Measured: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
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.
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
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.
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
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.
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Cardiorespiratory fitness (peak oxygen consumption)
Peak oxygen consumption (VO2peak) in ml/min and in ml/min/kg 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).
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
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).
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
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).
Measured: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start28 Jul 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Patt, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852156
- Sponsor's protocol ID
- 2026-01492
- Other IDs
- 2025-25
- Acronym
- CoolEx
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Inpatient Rehabilitation - Investigating the Effects of Cooling During Intensive Active Training Sessions on Fatigue in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07852156
- Acronym / sponsor ID
- CoolEx / 2026-01492
- Conditions
- Multiple Sclerosis, Heat Tolerance, Fatigue Symptom
- Keywords
- cooling, exercise training, Multiple sclerosis, multidisciplinary rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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/weeks.
This 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/her own control to minimize inter-individual variability.
The 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.
Experimental period:
The 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.
Control period:
The control period consists of the multidisciplinary inpatient rehabilitation program without cooling during intensive active training sessions.
Multidisciplinary inpatient rehabilitation:
The 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.
There are six measurement timepoints in this study:
- T-1: endpoint assessment at baseline (pre-intervention/control (clinic entry))
- T0: baseline endpoint assessment 1st week of intervention/control
- T1: endpoint assessment after week 1 of intervention/control
- T2: baseline endpoint assessment 2nd week of intervention/control
- T3: endpoint assessment after week 2 of intervention/control
- T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
State 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.
Additionally, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Wearing a cooling vest during intensive, active training sessionsThe 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. |
| Control | Other | Other: ControlThe control period consists of the usual multidisciplinary inpatient rehabilitation program without cooling for one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing a cooling vest during intensive, active training sessionsThe 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. | Other | Intervention |
| ControlThe control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling. | Other | Control |
Primary outcome
State Fatigue
Time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
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.
10 secondary outcomes
Walking capacity
Time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
Functional lower extremity muscle strength
Time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
Balance
Time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
Cognition
Time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control
Trait fatigue
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Muscle strength - upper extremity (row machine)
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Muscle strength - lower extremity (leg press)
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Cardiorespiratory fitness (peak oxygen consumption)
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Cardiorespiratory fitness (peak maximum power output)
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Cardiorespiratory fitness (peak heartrate)
Time frame: T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing a cooling vest during intensive, active training sessions in people with Multiple Sclerosis and Heat Tolerance, run by Klinik Valens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Patt, M.Sc. (+41 58 511 13 83, nadine.patt@kliniken-valens.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Fatigue (time frame: T0: baseline endpoint assessment 1st week of intervention/control T1: endpoint assessment after week 1 of intervention/control T2: baseline endpoint assessment 2nd week of intervention/control T3: endpoint assessment after week 2 of intervention/control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.