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

Primary Purpose

Multiple Sclerosis, Weakness, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cross-Training healthy subjects
Cross-Training multiple sclerosis
Standard-training multiple sclerosis
Sponsored by
Università degli Studi di Sassari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Resistance training/methods, contralateral strength training, ipsilateral strength training, Isokinetic contraction, Adaptation, Physiological/physiology, Electromyography/methods, Transcranial Magnetic Stimulation/methods, Evoked Potentials, Motor

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Biomedical Sciences- University of Sassari
  • Department of Clinical and Experimental Medicine, University of Sassari
  • Department of Surgery, Microsurgery and Medical-Surgical Specialties

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

Cross-Training healthy subjects

Standard-Training multiple sclerosis

Cross-Training multiple sclerosis

Healthy Control

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2013
Last Updated
March 27, 2017
Sponsor
Università degli Studi di Sassari
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1. Study Identification

Unique Protocol Identification Number
NCT02010398
Brief Title
Effects of the Cross-Training in Patients With Multiple Sclerosis
Acronym
CTSM
Official Title
Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
March 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cross-Training healthy subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard-Training multiple sclerosis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cross-Training multiple sclerosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
A cohort of healthy subjects (N=15) will undergo baseline assessment and a second evaluation after one month of no-intervention
Intervention Type
Other
Intervention Name(s)
Cross-Training healthy subjects
Intervention Description
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
Intervention Name(s)
Cross-Training multiple sclerosis
Intervention Description
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
Intervention Name(s)
Standard-training multiple sclerosis
Intervention Description
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 Outcome Measure Information:
Title
Muscular strength
Description
Strength changes in the weaker side compared to the contralateral, through isokinetic dynamometry.
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.
Secondary Outcome Measure Information:
Title
Neural adaptations to Cross Training
Description
Neural adaptations to CT occurring at cortical and/or spinal level, through transcranial magnetic stimulation (TMS) and peripheral electrophysiological recordings.
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.
Other Pre-specified Outcome Measures:
Title
Walking performance
Description
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.
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.
Title
Fatigue
Description
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.
Time Frame
Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
Title
Executive functions
Description
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.
Time Frame
Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
Title
Spasticity symptom severity
Description
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).
Time Frame
Assessment at baseline, within one week from the completion of the 6-week rehabilitation phase and at 12-week follow up.
Title
Gait Analysis for patients with Multiple Sclerosis
Time Frame
At baseline and post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franca Deriu, MD; PhD
Organizational Affiliation
University of Sassari-Department of Biomedical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Department of Biomedical Sciences- University of Sassari
City
Sassari
State/Province
Sassari (SS)
ZIP/Postal Code
07100
Country
Italy
Facility Name
Department of Clinical and Experimental Medicine, University of Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Department of Surgery, Microsurgery and Medical-Surgical Specialties
City
Sassari
ZIP/Postal Code
07100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25922111
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.
Results Reference
result
PubMed Identifier
32266379
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.
Results Reference
derived
PubMed Identifier
31100700
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, Avon). 2019 Jul;67:102-106. doi: 10.1016/j.clinbiomech.2019.05.008. Epub 2019 May 9.
Results Reference
derived
PubMed Identifier
28342828
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.
Results Reference
derived
PubMed Identifier
28251398
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.
Results Reference
derived
PubMed Identifier
27485469
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.
Results Reference
derived
PubMed Identifier
26637645
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25922111?report=docsum&format=text
Description
A comprehensive assessment of the cross-training effect in ankle dorsiflexors of healthy subjects: A randomized controlled study.

Learn more about this trial

Effects of the Cross-Training in Patients With Multiple Sclerosis

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