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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452760
• Other study ID #: UCAM-CE071923
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: October 5, 2020

Study information

• Verified date: October 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 5, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Physical exercise
Physical exercise intervention
• Testing sessions
Testing sessions

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Rate of Force Development	Rate of force development in knee extension	Before the program training
Primary	Rate of Force Development	Rate of force development in knee extension	After 10 weeks
Primary	Central Activation Ratio	The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions	Before the program training
Primary	Central Activation Ratio	The central activation ratio (CAR) was determined using superimposed electrical stimulation during maximum voluntary contractions	After 10 weeks
Primary	Spasticity	Pendulum test	Before the program training
Primary	Spasticity	Pendulum test	After 10 weeks
Secondary	Walking speed	Test 10 m-walks	Before the program training
Secondary	Walking speed	Test 10 m-walks	After 10 weeks
Secondary	Static Balance	Romberg Test with eyes open and closed. Analysis with force plates	Before the program training
Secondary	Static Balance	Romberg Test with eyes open and closed. Analysis with force plates	After 10 weeks
Secondary	Functional capacity	Sit-to-Stand Test	Before the program training
Secondary	Functional capacity	Sit-to-Stand Test	After 10 weeks
Secondary	Heart Rate Variability	Sleeping Heart Rate Variability	Before the program training
Secondary	Heart Rate Variability	Sleeping Heart Rate Variability	After 10 weeks
Secondary	Sleep Quality	Acelerometry and Karolinska Sleep Diary	Before the program training
Secondary	Sleep Quality	Acelerometry and Karolinska Sleep Diary	After 10 weeks