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Completed

NCT Number: NCT04452760

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyssomnias Immune System Diseases Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Católica San Antonio

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise

Other

Physical exercise intervention

Testing sessions

Other

Testing sessions

Primary outcomes

  1. 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.

  2. 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.

  3. Rate of Force Development

    Time frame: Before the program training

    Rate of force development in knee extension

  4. Rate of Force Development

    Time frame: After 10 weeks

    Rate of force development in knee extension

  5. Central Activation Ratio

    Time frame: Before the program training

    The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions

  6. Central Activation Ratio

    Time frame: After 10 weeks

    The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions

  7. Spasticity

    Time frame: Before the program training

    Pendulum test

  8. Spasticity

    Time frame: After 10 weeks

    Pendulum test

Secondary outcomes

  1. Walking speed

    Time frame: Before the program training

    Test 10 m-walks

  2. Walking speed

    Time frame: After 10 weeks

    Test 10 m-walks

  3. Static Balance

    Time frame: Before the program training

    Romberg Test with eyes open and closed. Analysis with force plates

  4. Static Balance

    Time frame: After 10 weeks

    Romberg Test with eyes open and closed. Analysis with force plates

  5. Functional capacity

    Time frame: Before the program training

    Sit-to-Stand Test

  6. Functional capacity

    Time frame: After 10 weeks

    Sit-to-Stand Test

  7. Heart Rate Variability

    Time frame: Before the program training

    Sleeping Heart Rate Variability

  8. Heart Rate Variability

    Time frame: After 10 weeks

    Sleeping Heart Rate Variability

  9. Sleep Quality

    Time frame: Before the program training

    Acelerometry and Karolinska Sleep Diary

  10. Sleep Quality

    Time frame: After 10 weeks

    Acelerometry and Karolinska Sleep Diary

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 30, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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