Effects of the Cross-Training in Patients With Multiple Sclerosis

NCT02010398 | Completed DMC

• 1 other identifier: Prot.1160/L
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine whether, in patients with multiple sclerosis presenting with marked asymmetry of strength, training the less-affected limb with a Cross-Training approach may induce a meaningful transfer of strength with neurophysiological, functional and clinical correlates, to the contralateral, more-impaired limb.

Conditions

Multiple Sclerosis; Weakness; Fatigue

Keywords

Resistance training/methods; contralateral strength training; ipsilateral strength training; Isokinetic contraction; Adaptation, Physiological/physiology; Electromyography/methods; Transcranial Magnetic Stimulation/methods; Evoked Potentials, Motor

Outcome Measures

Primary Outcomes (1)

• Muscular strength

  Strength changes in the weaker side compared to the contralateral, through isokinetic dynamometry.

  Muscular strength will be assessed at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.

Secondary Outcomes (1)

• Neural adaptations to Cross Training

  Neural adaptations will be assessed at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.

Other Outcomes (5)

• Walking performance

  It will be assessed at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.

• Fatigue

  Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.

• Executive functions

  Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.

Study Arms (4)

Cross-Training healthy subjects

ACTIVE COMPARATOR

A cohort of healthy subjects (N=15) will undergo a phase of intervention consisting of cross-training of the stronger limb employing an isokinetic contraction regimen at maximal intensity.

Other: Cross-Training healthy subjects

Standard-Training multiple sclerosis

ACTIVE COMPARATOR

A cohort of patients with multiple sclerosis (N=15), presenting with a marked asymmetry in limb strength, will undergo a standard-training of the more-impaired limb employing an isokinetic contraction regimen at maximal intensity.

Other: Standard-training multiple sclerosis

Cross-Training multiple sclerosis

EXPERIMENTAL

A cohort of patients with multiple sclerosis (N=15), presenting with a marked asymmetry in limb strength, will undergo a cross-training of the less-impaired limb employing an isokinetic contraction regimen at maximal intensity.

Other: Cross-Training multiple sclerosis

Healthy Control

NO INTERVENTION

A cohort of healthy subjects (N=15) will undergo baseline assessment and a second evaluation after one month of no-intervention

Interventions

Cross-Training healthy subjects OTHER

The phase of intervention will consist of a 6-week cross-training of the stronger limb employing an isokinetic contraction regimen at maximal intensity.

Cross-Training healthy subjects

Cross-Training multiple sclerosis OTHER

The phase of intervention will consist of a 6-week cross-training of the less-impaired limb employing an isokinetic contraction regimen at maximal intensity.

Cross-Training multiple sclerosis

Standard-training multiple sclerosis OTHER

The phase of intervention will consist of a 6-week standard strength training of the more-impaired limb employing an isokinetic contraction regimen performed at maximal intensity.

Standard-Training multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• Expanded Disability Status Scale (EDSS) ≤6 (Pyramidal functional system ≥3)

You may not qualify if:

• Clinically relevant cognitive disorders;
• Disability caused by other diseases;
• Medication with corticosteroids within three months prior to enrolment;
• Medication with botulinum toxin within six months prior to enrolment;
• Clinically or radiologically documented exacerbation within six months prior to enrolment;
• Variations in disease-modifying drugs (DMD) within three months prior to enrolment;
• Severe ataxia and postural instability (assessed with Berg Balance Scale);
• Depression

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (3)

Department of Biomedical Sciences- University of Sassari

Sassari, Sassari (SS), 07100, Italy

Location

Department of Clinical and Experimental Medicine, University of Sassari

Sassari, 07100, Italy

Location

Department of Surgery, Microsurgery and Medical-Surgical Specialties

Sassari, 07100, Italy

Location

Related Publications (8)

• Manca A, Pisanu F, Ortu E, De Natale ER, Ginatempo F, Dragone D, Tolu E, Deriu F. A comprehensive assessment of the cross-training effect in ankle dorsiflexors of healthy subjects: A randomized controlled study. Gait Posture. 2015 Jun;42(1):1-6. doi: 10.1016/j.gaitpost.2015.04.005. Epub 2015 Apr 20.

  PMID: 25922111 RESULT

• Morrone M, Martinez G, Achene A, Scaglione M, Masala S, Manca A, Deriu F. Size and site matter: the influence of corpus callosum subregional lesions on the magnitude of cross-education of strength. Front Physiol. 2025 Feb 24;16:1554742. doi: 10.3389/fphys.2025.1554742. eCollection 2025.

  PMID: 40066282 DERIVED

• Manca A, Martinez G, Aiello E, Ventura L, Deriu F. Effect of Eccentric Strength Training on Elbow Flexor Spasticity and Muscle Weakness in People With Multiple Sclerosis: Proof-of-Concept Single-System Case Series. Phys Ther. 2020 Jul 19;100(7):1142-1152. doi: 10.1093/ptj/pzaa055.

  PMID: 32266379 DERIVED

• Manca A, Martinez G, Cereatti A, Della Croce U, Ventura L, Dvir Z, Deriu F. Isokinetic predictors of gait speed increase following high-intensity resistance training of the ankle dorsiflexors in people with multiple sclerosis: A pilot study. Clin Biomech (Bristol). 2019 Jul;67:102-106. doi: 10.1016/j.clinbiomech.2019.05.008. Epub 2019 May 9.

  PMID: 31100700 DERIVED

• Manca A, Cabboi MP, Dragone D, Ginatempo F, Ortu E, De Natale ER, Mercante B, Mureddu G, Bua G, Deriu F. Resistance Training for Muscle Weakness in Multiple Sclerosis: Direct Versus Contralateral Approach in Individuals With Ankle Dorsiflexors' Disparity in Strength. Arch Phys Med Rehabil. 2017 Jul;98(7):1348-1356.e1. doi: 10.1016/j.apmr.2017.02.019. Epub 2017 Mar 23.

  PMID: 28342828 DERIVED

• Manca A, Dvir Z, Dragone D, Mureddu G, Bua G, Deriu F. Time course of strength adaptations following high-intensity resistance training in individuals with multiple sclerosis. Eur J Appl Physiol. 2017 Apr;117(4):731-743. doi: 10.1007/s00421-017-3534-z. Epub 2017 Mar 1.

  PMID: 28251398 DERIVED

• Manca A, Ginatempo F, Cabboi MP, Mercante B, Ortu E, Dragone D, De Natale ER, Dvir Z, Rothwell JC, Deriu F. No evidence of neural adaptations following chronic unilateral isometric training of the intrinsic muscles of the hand: a randomized controlled study. Eur J Appl Physiol. 2016 Oct;116(10):1993-2005. doi: 10.1007/s00421-016-3451-6. Epub 2016 Aug 2.

  PMID: 27485469 DERIVED

• Manca A, Cabboi MP, Ortu E, Ginatempo F, Dragone D, Zarbo IR, de Natale ER, Mureddu G, Bua G, Deriu F. Effect of Contralateral Strength Training on Muscle Weakness in People With Multiple Sclerosis: Proof-of-Concept Case Series. Phys Ther. 2016 Jun;96(6):828-38. doi: 10.2522/ptj.20150299. Epub 2015 Dec 4.

  PMID: 26637645 DERIVED

Related Links

• A comprehensive assessment of the cross-training effect in ankle dorsiflexors of healthy subjects: A randomized controlled study.
• Resistance training for muscle weakness in multiple sclerosis: direct versus contralateral approach in individuals with ankle dorsiflexors' disparity in strength.

MeSH Terms

Conditions

Multiple Sclerosis; Asthenia; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Franca Deriu, MD; PhD

  University of Sassari-Department of Biomedical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: July 1, 2013
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

IT (3)