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Completed

NCT Number: NCT02010398

Effects of the Cross-Training in Patients With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Asthenia Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Weakness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Sciences- University of Sassari, Sassari, Sassari (SS), Italy

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. Muscular strength

    Time frame: 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.

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

Secondary outcomes

  1. Neural adaptations to Cross Training

    Time frame: 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.

    Neural adaptations to CT occurring at cortical and/or spinal level, through transcranial magnetic stimulation (TMS) and peripheral electrophysiological recordings.

Other outcomes

  1. Walking performance

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

    Regarding the clinical and functional relevance to MS patients, changes from baseline in walking performance will be assessed through 6-Minute Walking Test (6MWT), which has been demonstrated to be a feasible, reproducible and reliable measure in MS and to be strongly correlated to subjective measures of ambulation; 10 Meter-Walk Test (10MWT), which estimates the walking speed at both comfortable and maximal velocities.

  2. Fatigue

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

    Modified Fatigue Impact Scale (MFIS): extracted from the Multiple Sclerosis Quality of Life Inventor. It consists of 21 items and provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning.

  3. Executive functions

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

    Frontal Assessment Battery (FAB): it tests executive functions, in a form of an interview with 6 functional tasks covering 5 domains: memory, planning, attention, reflex and visual spatial. The FAB correlates with dysfunction in a variety of cognitive domains including attention, memory, and executive functions.

  4. Spasticity symptom severity

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

    Modified Ashworth Scale: it is a widely used qualitative scale for the assessment of spasticity symptom severity and measures resistance to passive stretch, scoring from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).

  5. Gait Analysis for patients with Multiple Sclerosis

    Time frame: At baseline and post-intervention

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Official study title

Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect in Patients With Multiple Sclerosis

Acronym: CTSM

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2013
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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