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

NCT04452760 | Completed

• 1 other identifier: UCAM-CE071923
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

neurological disorders; resistance training; strength training; sleep quality; neuromuscular performance; functional capacity

Outcome Measures

Primary Outcomes (8)

• 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

• Spasticity

  Pendulum test

  Before the program training

• Spasticity

  Pendulum test

  After 10 weeks

Secondary Outcomes (10)

• Walking speed

  Before the program training

• Walking speed

  After 10 weeks

• Static Balance

  Before the program training

• Static Balance

  After 10 weeks

• Functional capacity

  Before the program training

Study Arms (2)

Control group

ACTIVE COMPARATOR

Only testing sessions

Other: Testing sessions

Progressive resistance training group

EXPERIMENTAL

10-weeks of progressive resistance training group. Leg press, leg extension, calf raises, hip extension exercises.

Other: Physical exercise; Other: Testing sessions

Interventions

Physical exercise OTHER

Physical exercise intervention

Progressive resistance training group

Testing sessions OTHER

Testing sessions

Control group; Progressive resistance training group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild or moderate disability with clinical mild spastic-ataxic gait disorder.
• stable phase of the disease.

You may not qualify if:

• Expanded Disability Status Scale (EDSS) \< 6.
• relapsing disease within the preceding 12 months.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio

Murcia, 30107, Spain

Location

Related Publications (2)

• 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.

  PMID: 35905806 DERIVED

• 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.

  PMID: 34107841 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Nervous System Diseases; Sleep Initiation and Maintenance Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jacobo Á Rubio-Arias, Dr

  Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 30, 2020
• Study Start: July 15, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 5, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the completion of study
• Access Criteria: The data will be published in a journal

Locations

ES (1)