MSFrontier

CoolEx

Optimizing Inpatient Rehabilitation - Investigating the Effects of Cooling During Intensive Active Training Sessions on Fatigue in Persons With Multiple Sclerosis
RecruitingNot a drug-phase studyRelapsing and progressiveNCT07852156

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Wearing a cooling vest during intensive, active training sessions
  • Control

What it measured

Main measures

  • State Fatigue

    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: end

    Fatigue

Other measures (10)

  • Walking capacity

    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: end

    Walking and mobility

  • Functional lower extremity muscle strength

    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: end

    Physical function

  • Balance

    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: end

    Walking and mobility

  • Cognition

    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: end

    Thinking and memory

  • Trait fatigue

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Thinking and memoryFatigue

  • Muscle strength - upper extremity (row machine)

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Arm and hand functionPhysical function

  • Muscle strength - lower extremity (leg press)

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Physical function

  • Cardiorespiratory fitness (peak oxygen consumption)

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Physical function

  • Cardiorespiratory fitness (peak maximum power output)

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Physical function

  • Cardiorespiratory fitness (peak heartrate)

    T-1: endpoint assessment at pre-intervention/control (clinic entry) T4: endpoint assessment post-intervention/control (3 weeks after clinic entry)

    Physical function

Who could take part

Relapsing and progressive · 18 and over

Inclusion Criteria: * FSMC total score ≥ 43; * Adult age (≥ 18 years); * A definite MS diagnosis according to the 2024 revised McDonald criteria with relapsing-remitting, primary or secondary progressive phenotypes; * Disease severity according to Expanded disability status scale (EDSS) score 3.0-6.0; * Subjective perceived heat sensitivity (Yes). Exclusion Criteria: * Inability to follow the study procedures (i.e. participant not fluent in oral and written German language); * Cognitive impairment (Montreal Cognitive Assessment, MoCA score \< 26); * Severe concomitant disease states (i.e. orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological disease states, other serious medical conditions) impairing the ability to participate; * Participation in another study; * Pregnant or lactating women; * Intention to become pregnant during this study; * Suspected non-compliance; * Previous enrolment into this study; * Sudden severe disease progression or falling sick (e.g. bacterial or viral infections) during the study; * Subjective perceived cold sensitivity (Yes).

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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

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History

    1. Started

      Jul 2026

    2. Main results due

      Sept 2028

    3. Finished

      Sept 2028

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