Clinical trial NCT05562414: Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis
Official title: Transient and Immediate Motor Effects of Exercise in Progressive Multiple Sclerosis: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis, Chronic Progressive
High-Intensity Interval Training
Motor Symptoms
Keywords: Multiple Sclerosis, Chronic Progressive
Physical Conditioning, Human
Paraparesis
Gait
Dexterity
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centre Randomized Controlled Trial (RCT)
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Functional mobility
timeFrame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Secondary outcomes:
measure: Spasticity (objective)
timeFrame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
measure: Spasticity (subjective)
timeFrame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
measure: Gait pattern
timeFrame: Change from baseline to directly after, 1-hour after, 3-hours after and 5-hours after the exercise bout
measure: Dexterity
timeFrame: Change from baseline to directly after, 1-hour after, 3-hours after, and 5-hours after the exercise bout
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Klinik Valens, Valens rehabilitation clinic
state: Sankt Gallen
Study officials:
affiliation: Kliniken Valens
name: Roman Gonzenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.
citation: Ensari I, Motl RW, Pilutti LA. Exercise training improves depressive symptoms in people with multiple sclerosis: results of a meta-analysis. J Psychosom Res. 2014 Jun;76(6):465-71. doi: 10.1016/j.jpsychores.2014.03.014. Epub 2014 Mar 31.
citation: Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
citation: Taul-Madsen L, Connolly L, Dennett R, Freeman J, Dalgas U, Hvid LG. Is Aerobic or Resistance Training the Most Effective Exercise Modality for Improving Lower Extremity Physical Function and Perceived Fatigue in People With Multiple Sclerosis? A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2021 Oct;102(10):2032-2048. doi: 10.1016/j.apmr.2021.03.026. Epub 2021 Apr 24.
citation: Ward M, Goldman MD. Epidemiology and Pathophysiology of Multiple Sclerosis. Continuum (Minneap Minn). 2022 Aug 1;28(4):988-1005. doi: 10.1212/CON.0000000000001136.
citation: Bansi J, Koliamitra C, Bloch W, Joisten N, Schenk A, Watson M, Kool J, Langdon D, Dalgas U, Kesselring J, Zimmer P. Persons with secondary progressive and relapsing remitting multiple sclerosis reveal different responses of tryptophan metabolism to acute endurance exercise and training. J Neuroimmunol. 2018 Jan 15;314:101-105. doi: 10.1016/j.jneuroim.2017.12.001. Epub 2017 Dec 6.