Effects of the Cross-Training in Patients With Multiple Sclerosis (CTSM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Università degli Studi di Sassari
Sponsor:
Information provided by (Responsible Party):
Professor Franca Deriu, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT02010398
First received: December 9, 2013
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Weakness
Fatigue
Other: Cross-Training healthy subjects
Other: Cross-Training multiple sclerosis
Other: Standard-training multiple sclerosis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Sassari:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Strength changes in the weaker side compared to the contralateral, through isokinetic dynamometry.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Neural adaptations to CT occurring at cortical and/or spinal level, through transcranial magnetic stimulation (TMS) and peripheral electrophysiological recordings.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.

  • Fatigue [ Time Frame: Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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).

  • Gait Analysis for patients with Multiple Sclerosis [ Time Frame: At baseline and post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.
Experimental: 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.
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.
No Intervention: Healthy Control
A cohort of healthy subjects (N=15) will undergo baseline assessment and a second evaluation after one month of no-intervention

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010398

Contacts
Contact: Maria Paola Cabboi, MD +39 079228153 mariapaolacabboi@tiscali.it
Contact: Roberto Zarbo, MD +39 079228153 robertozarbo@gmail.com

Locations
Italy
Department of Biomedical Sciences- University of Sassari Recruiting
Sassari, Sassari (SS), Italy, 07100
Contact: Maria Paola Cabboi, MD    +39 079228153    mariapaolacabboi@tiscali.it   
Contact: Andrea Manca, BSc PT    +39 079228294    andmanca@uniss.it   
Principal Investigator: Franca Deriu, MD; PhD         
Principal Investigator: Andrea Manca, BSc PT         
Sub-Investigator: Francesco Pisanu, MD         
Sub-Investigator: Francesca Ginatempo, BSc         
Sub-Investigator: Enzo Ortu, MD; PhD         
Sub-Investigator: Daniele Dragone, BSc PT         
Sub-Investigator: Edoardo R De Natale, MD         
Sub-Investigator: Gabriele Paolini, Eng         
Sub-Investigator: Giovanni Mureddu, BSc PT         
Department of Clinical and Experimental Medicine, University of Sassari Recruiting
Sassari, Italy, 07100
Contact: Maura Pugliatti, MD; PhD    +39 079228231    maurap@uniss.it   
Sub-Investigator: Roberto Zarbo, MD         
Department of Surgery, Microsurgery and Medical-Surgical Specialties Active, not recruiting
Sassari, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
Study Director: Franca Deriu, MD; PhD University of Sassari-Department of Biomedical Sciences
  More Information

No publications provided

Responsible Party: Professor Franca Deriu, Associate Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT02010398     History of Changes
Other Study ID Numbers: Prot.1160/L
Study First Received: December 9, 2013
Last Updated: August 22, 2014
Health Authority: Italy: National Bioethics Committee

Keywords provided by Università degli Studi di Sassari:
Resistance training/methods
contralateral strength training
ipsilateral strength training
Isokinetic contraction
Adaptation, Physiological/physiology
Electromyography/methods
Transcranial Magnetic Stimulation/methods
Evoked Potentials, Motor

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014