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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • Rehabilitation clinic Valens

    Valens, Canton of St. Gallen, 7317

    Recruiting

Other trials in Switzerland

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.

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 groups in NCT07852156
Study groupRoleWhat they receive
InterventionExperimentalThe 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
ControlOtherThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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.

  1. First posted1 Oct 2026
  2. Study start28 Jul 2026
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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)
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

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.

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