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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452760
Recruitment Status : Active, not recruiting
First Posted : June 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jacobo Á. Rubio, Universidad Católica San Antonio de Murcia

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Physical exercise Other: Testing sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Ten-Weeks Progressive Resistance Training on Neuromuscular Performance, Mobility, Heart Rate Variability and Sleep Quality in Persons With Multiple Sclerosis
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Only testing sessions
Other: Testing sessions
Testing sessions

Experimental: Progressive resistance training group
10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.
Other: Physical exercise
Physical exercise intervention

Other: Testing sessions
Testing sessions




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452760


Locations
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Spain
Universidad Católica San Antonio
Murcia, Spain, 30107
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
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Principal Investigator: Jacobo Á Rubio-Arias, Dr Universidad Politécnica de Madrid
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Responsible Party: Jacobo Á. Rubio, Principal Investigator, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT04452760    
Other Study ID Numbers: UCAM-CE071923
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be published in a journal
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: After the completion of study
Access Criteria: The data will be published in a journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacobo Á. Rubio, Universidad Católica San Antonio de Murcia:
neurological disorders
resistance training
strength training
sleep quality
neuromuscular performance
functional capacity
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases