Status unknownNot a drug-phase studyProgressive MSNCT05562414

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • HIIT

Compared with

  • MCT

What it measured

Main measures

  • Functional mobility

    Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

    MRI lesionsWalking and mobility

Other measures (4)

  • Spasticity (objective)

    Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

    MRI lesionsSpasticity
  • Spasticity (subjective)

    Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

    MRI lesionsSpasticity
  • Gait pattern

    Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout

    MRI lesionsWalking and mobility
  • Dexterity

    Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout

    MRI lesionsArm and hand function

Who could take part

Progressive MS · 18 and over

Inclusion Criteria: * adult age (≥ 18 years) * definite MS diagnosis according the 2017 revised McDonald criteria * PPMS/SPMS phenotype according to the 2013 revised Lublin criteria * Expanded Disability Status Scale (EDSS) score ≤ 6.0 * Informed Consent as documented by signature of participants and PI Exclusion Criteria: * severe lower extremity spasticity or severe concomitant disease states (i.e., orthopaedic, cardiovascular, metabolic, psychiatric (e.g., substance abuse), other neurological, other serious medical conditions) impairing the ability to participate * inability to follow study procedures (e.g., due to language barriers) * suspected non-compliance * previous enrolment into the current study * enrolment of the investigator, his/her family members, employees, and other dependent persons

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

About this trial

In the sponsor's words

Endurance training is a cornerstone of rehabilitation in Multiple Sclerosis (MS) due to its beneficial effects on multiple MS-related symptoms, such as health-related quality of life, aerobic capacity (VO2peak), functional mobility, gait, depressive symptoms, and fatigue. Persons with progressive phenotypes of MS, namely primary progressive MS (PPMS) and secondary progressive (SPMS), represent a minor proportion of the total MS population, thus having been underrepresented in previous studies. The generalizability of existing evidence may be compromised by differences in symptom expression between MS phenotypes, with a dominance of motor symptoms (i.e., paraspasticity and/or paraparesis) in PPMS and SPMS. Adding up to this, clinical experiences of neurologists and sports scientists reveal that the effects of endurance exercise are characterized by a distinct time course, firstly inducing a minor and transient deterioration of motor symptoms that is followed by motor symptom alleviation beyond baseline level. This phenomenon was mainly related to the performance of High-Intensity Interval training (HIIT), but not to moderate-intensity continuous training (MCT). Therefore, this pilot study aims to systematically investigate the time course of acute motor effects on spasticity, functional mobility, gait, and dexterity in persons with PPMS and SPMS following two different endurance training protocols, that are HIIT and MCT.

Papers

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History

    1. Started

      Oct 2022

    2. Main results due

      Apr 2023

    3. Finished

      Apr 2023

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