NCT07852156

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
25mo left

Started Jul 2026

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Sep 2028

Study Start

First participant enrolled

July 28, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

September 16, 2026

Last Update Submit

September 25, 2026

Conditions

Multiple SclerosisHeat ToleranceFatigue Symptom

Keywords

coolingexercise trainingMultiple sclerosismultidisciplinary rehabilitation

Outcome Measures

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.

    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

    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

    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

    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

    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

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

  • +5 more secondary outcomes

Other Outcomes (12)

  • Sample characteristics - demographic data (age)

    At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).

  • Sample characteristics - demographic data (sex)

    At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).

  • Sample characteristics - anthropometric data (height)

    At measurement timepoint T-1 (endpoint assessment at baseline (pre-intervention/control (clinic entry)).

  • +9 more other outcomes

Study Arms (2)

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.

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.

Other: Control

Interventions

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.

Intervention
ControlOTHER

The control period consists of one week of the usual multidisciplinary inpatient rehabilitation program without cooling.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation clinic Valens

Valens, Canton of St. Gallen, 7317, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Nadine Patt, M.Sc.

CONTACT

+41 58 511 13 83nadine.patt@kliniken-valens.ch

Jens Bansi, Dr.

CONTACT

+41 58 511 13 02jens.bansi@kliniken-valens.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

September 16, 2026

First Posted

October 1, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

CH(1)