Clinical trial NCT04452760: Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Official title: Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: neurological disorders
resistance training
strength training
sleep quality
neuromuscular performance
functional capacity
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Strength training has been shown to improve strength and mobility in persons with MS.

Detailed description: Multiple Sclerosis (ME) is a degenerative, inflammatory and autoimmune demyelinating disease of the central nervous system, characterized by demyelination due to inflammation and degeneration of the myelin sheaths enveloping nerves of the eye, periventricular grey matter, brain, spinal cord and brainstem. The symptoms associated with MS include symptomatic fatigue, muscle weakness, ataxia, mobility and balance problems or cognitive problems. Resistance training has been shown to improve strength, sleep quality and mobility in persons with MS.

Eligibility criteria: Inclusion Criteria:

* mild or moderate disability with clinical mild spastic-ataxic gait disorder.
* stable phase of the disease.

Exclusion Criteria:

* Expanded Disability Status Scale (EDSS) \< 6.
* relapsing disease within the preceding 12 months.
* corticosteroid treatment within the last months before study inclusion.

Primary outcomes:
measure: Maximal Voluntary Isometric Contraction of Knee Extension
timeFrame: Before the program training
measure: Maximal Voluntary Isometric Contraction of Knee Extension
timeFrame: After 10 weeks
measure: Rate of Force Development
timeFrame: Before the program training
measure: Rate of Force Development
timeFrame: After 10 weeks
measure: Central Activation Ratio
timeFrame: Before the program training
measure: Central Activation Ratio
timeFrame: After 10 weeks
measure: Spasticity
timeFrame: Before the program training
measure: Spasticity
timeFrame: After 10 weeks
Secondary outcomes:
measure: Walking speed
timeFrame: Before the program training
measure: Walking speed
timeFrame: After 10 weeks
measure: Static Balance
timeFrame: Before the program training
measure: Static Balance
timeFrame: After 10 weeks
measure: Functional capacity
timeFrame: Before the program training
measure: Functional capacity
timeFrame: After 10 weeks
measure: Heart Rate Variability
timeFrame: Before the program training
measure: Heart Rate Variability
timeFrame: After 10 weeks
measure: Sleep Quality
timeFrame: Before the program training
measure: Sleep Quality
timeFrame: After 10 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Jacobo Á Rubio-Arias, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreu-Caravaca L, Ramos-Campo DJ, Chung LH, Rubio-Arias JA. Can strength training modify voluntary activation, contractile properties and spasticity in Multiple Sclerosis?: A randomized controlled trial. Physiol Behav. 2022 Oct 15;255:113932. doi: 10.1016/j.physbeh.2022.113932. Epub 2022 Jul 27.
citation: Andreu-Caravaca L, Ramos-Campo DJ, Abellan-Aynes O, Avila-Gandia V, Chung LH, Manonelles P, Rubio-Arias JA. 10-Weeks of resistance training improves sleep quality and cardiac autonomic control in persons with multiple sclerosis. Disabil Rehabil. 2022 Sep;44(18):5241-5249. doi: 10.1080/09638288.2021.1934738. Epub 2021 Jun 9.