Effects of the Cross-Training in Patients With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-03-27

Brief Summary

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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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Detailed Description

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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).

Conditions

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Multiple Sclerosis Weakness Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Cross-Training healthy subjects

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.

Group Type ACTIVE_COMPARATOR

Cross-Training healthy subjects

Intervention Type 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.

Standard-Training multiple sclerosis

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.

Group Type ACTIVE_COMPARATOR

Standard-training multiple sclerosis

Intervention Type 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.

Cross-Training multiple sclerosis

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.

Group Type EXPERIMENTAL

Cross-Training multiple sclerosis

Intervention Type 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.

Healthy Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cross-Training healthy subjects

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

Intervention Type OTHER

Cross-Training multiple sclerosis

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.

Intervention Type OTHER

Standard-training multiple sclerosis

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes