Cooling During Inpatient Rehabilitation in Persons With MS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKlinik Valens
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Wearing a cooling vest during intensive, active training sessions
Other interventionThe 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.
Control
Other interventionThe control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
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.
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/controlSecondary outcomes
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.
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/control2
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.
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/control3
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.
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/control4
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.
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/controlOther outcomes
1
Sample characteristics - demographic data (age)
The age of the participants will be assessed in years.
Time frame
At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).2
Sample characteristics - demographic data (sex)
The sex of the participants (female / male / diverse) will be recorded for the description of the study sample.
Time frame
At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).3
Sample characteristics - anthropometric data (height)
The participants' height will be recorded in meters.
Time frame
At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).4
Sample characteristics - anthropometric data (weight)
The weight of the participants will be assessed in kilograms.
Time frame
At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).Sponsors and contacts
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Source ClinicalTrials.gov