Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2020

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.

Interventions

  • Other: Physical exercise
    • Physical exercise intervention
  • Other: Testing sessions
    • Testing sessions

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • Only testing sessions
  • Experimental: Progressive resistance training group
    • 10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.

Clinical Trial Outcome Measures

Primary Measures

  • Maximal Voluntary Isometric Contraction of Knee Extension
    • Time Frame: Before the program training
    • the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
  • Maximal Voluntary Isometric Contraction of Knee Extension
    • Time Frame: After 10 weeks
    • the maximum force (N) that can be produced voluntarily by the knee extension muscles during an isometric contraction is measured. The leg of the participant is fixed to an isokinetic device, and the participant makes a 5-second attempt, developing all the strength he or she can.
  • Rate of Force Development
    • Time Frame: Before the program training
    • Rate of force development in knee extension
  • Rate of Force Development
    • Time Frame: After 10 weeks
    • Rate of force development in knee extension
  • Central Activation Ratio
    • Time Frame: Before the program training
    • The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
  • Central Activation Ratio
    • Time Frame: After 10 weeks
    • The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions
  • Spasticity
    • Time Frame: Before the program training
    • Pendulum test
  • Spasticity
    • Time Frame: After 10 weeks
    • Pendulum test

Secondary Measures

  • Walking speed
    • Time Frame: Before the program training
    • Test 10 m-walks
  • Walking speed
    • Time Frame: After 10 weeks
    • Test 10 m-walks
  • Static Balance
    • Time Frame: Before the program training
    • Romberg Test with eyes open and closed. Analysis with force plates
  • Static Balance
    • Time Frame: After 10 weeks
    • Romberg Test with eyes open and closed. Analysis with force plates
  • Functional capacity
    • Time Frame: Before the program training
    • Sit-to-Stand Test
  • Functional capacity
    • Time Frame: After 10 weeks
    • Sit-to-Stand Test
  • Heart Rate Variability
    • Time Frame: Before the program training
    • Sleeping Heart Rate Variability
  • Heart Rate Variability
    • Time Frame: After 10 weeks
    • Sleeping Heart Rate Variability
  • Sleep Quality
    • Time Frame: Before the program training
    • Acelerometry and Karolinska Sleep Diary
  • Sleep Quality
    • Time Frame: After 10 weeks
    • Acelerometry and Karolinska Sleep Diary

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad Católica San Antonio de Murcia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacobo Á. Rubio, Principal Investigator – Universidad Católica San Antonio de Murcia
  • Overall Official(s)
    • Jacobo Á Rubio-Arias, Dr, Principal Investigator, Universidad Politécnica de Madrid
  • Overall Contact(s)
    • Luis A Andreu-Caravaca, MsC, 697661913, landreu@ucam.edu

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