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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Testing sessions; Other: Physical exercise

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.

• 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 65 years (Adult, Older 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: Progressive resistance training group; 10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.	Other: Testing sessions; Testing sessions; Other: Physical exercise; Physical exercise intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spasticity	Pendulum test	Before the program training
Spasticity	Pendulum test	After 10 weeks
Maximal Voluntary Isometric Contraction of Knee Extension	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.	Before the program training
Maximal Voluntary Isometric Contraction of Knee Extension	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.	After 10 weeks
Rate of Force Development	Rate of force development in knee extension	Before the program training
Rate of Force Development	Rate of force development in knee extension	After 10 weeks
Central Activation Ratio	The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions	Before the program training
Central Activation Ratio	The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions	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
Heart Rate Variability	Sleeping Heart Rate Variability	Before the program training
Heart Rate Variability	Sleeping Heart Rate Variability	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
Sleep Quality	Acelerometry and Karolinska Sleep Diary	Before the program training
Sleep Quality	Acelerometry and Karolinska Sleep Diary	After 10 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: strength training; functional capacity; sleep quality; resistance training; neurological disorders; neuromuscular performance
• 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-CE071923

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 study
• IPD Sharing Access Criteria: The data will be published in a journal
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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