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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Testing sessions; Other: Physical exercise

• Registration Number: NCT04452760
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-06-30
• Study Start: 2020-07-15
• Status Verified: 2020-10
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-05
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Testing sessions	Only testing sessions
Progressive resistance training group	Testing sessions	10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.
Progressive resistance training group	Physical exercise	10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.

Primary Outcome Measures

Name	Time	Method
Rate of Force Development	After 10 weeks	Rate of force development in knee extension
Spasticity	After 10 weeks	Pendulum test
Maximal Voluntary Isometric Contraction of Knee Extension	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.
Central Activation Ratio	After 10 weeks	The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universidad Católica San Antonio; 🇪🇸 Murcia, Spain