Exercise on Multiple Sclerosis Patients

Effects of Head and Neck Cooling on Functional Ability and Fatigue of Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04125628

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Exercise with cooling

Compared with

  • Exercise without cooling

What it measured

Main measures

  • Core Temperature

    Change from baseline to after 40 minutes of continous cycling.

  • Functional ability test Handgrip

    Change from baseline to after 40 minutes of continous cycling.

    Arm and hand functionPhysical function

  • Functional ability test 2-minute walk

    Change from baseline to after 40 minutes of continous cycling.

    Walking and mobility

  • Functional ability test 25-Foot Walk (T25-FW)

    Change from baseline to after 40 minutes of continous cycling.

    Walking and mobility

  • Functional ability test five times sit-to-stand test (STS)

    Change from baseline to after 40 minutes of continous cycling.

    Walking and mobilityPhysical function

  • Functional ability test Berg Balance Scale (BBS)

    Change from baseline to after 40 minutes of continous cycling.

    Walking and mobility

  • Functional ability test level of fatigue severity (FSS)

    Change from baseline to after 40 minutes of continous cycling.

    Fatigue

  • Functional ability test Cognitive function

    Change from baseline to after 40 minutes of continous cycling.

    Thinking and memory

  • Functional ability test level of fatigue impact

    Change from baseline to after 40 minutes of continous cycling.

    Thinking and memoryFatigue

  • Functional ability test level of fatigue inventory

    Change from baseline to after 40 minutes of continous cycling.

    Fatigue

  • Functional ability test level of physical fatigue

    Change from baseline to after 40 minutes of continous cycling.

    Thinking and memoryFatigue

Who could take part

MS (type not specified)

Show the full criteria

Inclusion criteria

* Postmenopausal women (no menses for the last year at least); * Osteoporosis patients (female): T-score\<-2.5 at the femoral neck (or other anatomical site); * Osteoporosis patients (male): T-score\<-2.5 at the femoral neck (or other anatomical site) * Osteopenia patients (female): T-score\<-1.0 at the femoral neck (or other anatomical site); * Osteopenia patients (male): T-score\<-1.0 at the femoral neck (or other anatomical site) * Patients taking drugs/ supplements for osteoporosis will be accepted in the study after going through a wash-up period

Exclusion criteria

* Women with irregular menses (i.e. with no established menopause) * Patients taking medications for other diseases known to interfere with bone metabolism * Patients with other chronic diseases (e.g. diabetes)

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) patients are characterized by thermoregulatory failure, known as Uthoff's phenomenon. Precisely, 60-80% of the MS patients present adverse clinical symptoms when their body temperature is increased. Thus, the development of treatment strategies to overcome the thermoregulatory problem in these patients is crucial. Given that cooling has been proposed as an effective method, the aim of this study was to examine whether the application of head cooling therapy during an exercise training session is capable to prevent the core temperature increase and to improve the patient's functional ability and quality of life.

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History

    1. Started

      Jun 2019

    2. Main results due

      Jun 2019

    3. Finished

      Jun 2019

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