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

Effects of Ten-Weeks Resistance Training on Neuromuscular Performance, Heart Rate Variability, Sleep Quality and Mobility 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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Testing sessions; Other: Resistance training

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Universidad Católica San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Only testing sessions	Other: Testing sessions; Testing sessions
Experimental: Resistance training group; Ten weeks of resistance training	Other: Testing sessions; Testing sessions; Other: Resistance training; Ten weeks of resistance training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Voluntary Isometric Contraction of Knee Extension		Before the program training
Maximal Voluntary Isometric Contraction of Knee Extension		After 10 weeks
Rate of Force Development		Before the program training
Rate of Force Development		After 10 weeks
Central Activation Ratio		Before the program training
Central Activation Ratio		After 10 weeks
Spasticity	Pendulum test	Before the program training
Spasticity	Pendulum test	After 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	Test 10 m-walks	Before the program training
Walking speed	Test 10 m-walks	After 10 weeks
Static balance	Romberg Test with eyes open and closed. Analysis with force plates	Before the program training
Static balance	Romberg Test with eyes open and closed. Analysis with force plates	After 10 weeks
Functional capacity	Sit to stand test	Before the program training
Functional capacity	Sit to stand test	After 10 weeks
Heart Rate Variability	Sleeping Heart Rate Variability	Before the program training
Heart Rate Variability	Sleeping Heart Rate Variability	After 10 weeks
Sleep Quality	Karolinska Sleep Diary and Acelerometry	Before the program training
Sleep Quality	Karolinska Sleep Diary and Acelerometry	After 10 weeks

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Jacobo Á Rubio-Arias, Dr, Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: UCAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be published in a journal
• IPD Sharing Time Frame: After the completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No