Clinical trial NCT02010398: Effects of the Cross-Training in Patients With Multiple Sclerosis
Official title: Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Muscle weakness is a major disability that is responsible for deeply reducing the overall quality of life (QoL) of patients with Multiple Sclerosis (MS). Research has shown that strength training (ST) has a significant positive effect on the performance of daily living activities in people with MS, resulting in an increased QoL. Several ST methods are currently employed for reducing strength impairment in MS but no one regimen has been portrayed as superior to others. When strength impairment is prominently lateralized to one limb, training is commonly addressed to the weaker side in order to balance the deficit. However, such ST may not always be applicable to a severely weakened limb that is too compromised to sustain it. For these selected patients we hypothesize that training the less affected limb with a Cross Training (CT) approach may overcome the problem, also avoiding patients' frustration and potential withdrawals from rehabilitation programs.

Aim of this project is to investigate and compare in two groups of selected MS patients, with a marked asymmetry of strength, the effects induced on dynamometric, neurophysiological, functional and clinical outcomes by a CT of the less-impaired leg (CT group) compared to a ST of the more-impaired leg (ST group). In order to make comparisons with a population which is not exposed to the condition MS, a third group composed of healthy subjects will also be included in the study.

The research plan will be articulated in 5 phases (recruitment, baseline assessment, 6 week-intervention phase, post-intervention assessment and follow up at 12 weeks).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Muscular strength
timeFrame: 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:
measure: Neural adaptations to Cross Training
timeFrame: 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:
measure: Walking performance
timeFrame: It will be assessed at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
measure: Fatigue
timeFrame: Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
measure: Executive functions
timeFrame: Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
measure: Spasticity symptom severity
timeFrame: Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
measure: Gait Analysis for patients with Multiple Sclerosis
timeFrame: At baseline and post-intervention
Locations:
city: Sassari
country: Italy
facility: Department of Biomedical Sciences- University of Sassari
state: Sassari (SS)
city: Sassari
country: Italy
facility: Department of Clinical and Experimental Medicine, University of Sassari
city: Sassari
country: Italy
facility: Department of Surgery, Microsurgery and Medical-Surgical Specialties
Study officials:
affiliation: University of Sassari-Department of Biomedical Sciences
name: Franca Deriu, MD; PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.