Multiple SclerosisCTSMNCT02010398
Effects of the Cross-Training in Patients With Multiple Sclerosis
A study testing Cross-Training healthy subjects, Cross-Training multiple sclerosis and Standard-training multiple sclerosis in people with Multiple Sclerosis and Weakness, run by Università degli Studi di Sassari at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Weakness, Fatigue
- What is being tested?
- Cross-Training healthy subjects, Cross-Training multiple sclerosis and Standard-training multiple sclerosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesItaly
- Study dates
- Jul 2013to 27 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years
- Expanded Disability Status Scale (EDSS) ≤6 (Pyramidal functional system ≥3)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Biomedical Sciences- University of Sassari
Sassari, Sassari (SS), 07100
Department of Clinical and Experimental Medicine, University of Sassari
Sassari, 07100
Department of Surgery, Microsurgery and Medical-Surgical Specialties
Sassari, 07100
About this study
Official title: Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect 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.
Read the 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).
- Conditions
- Multiple Sclerosis, Weakness, Fatigue
- Being tested
- Cross-Training healthy subjects, Cross-Training multiple sclerosis, Standard-training multiple sclerosis
- Keywords
- Resistance training/methods, contralateral strength training, ipsilateral strength training, Isokinetic contraction, Adaptation, Physiological/physiology, Electromyography/methods, Transcranial Magnetic Stimulation/methods, Evoked Potentials, Motor
- Medical subject headings
- Multiple Sclerosis, Asthenia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-Training healthy subjectsOther
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 sclerosisOther
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 sclerosisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Training healthy subjects | Active comparator | 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. Receives: Other: Cross-Training healthy subjects |
| Standard-Training multiple sclerosis | Active comparator | 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. Receives: Other: Standard-training multiple sclerosis |
| Cross-Training multiple sclerosis | Experimental | 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. Receives: Other: Cross-Training multiple sclerosis |
| Healthy Control | No intervention | A cohort of healthy subjects (N=15) will undergo baseline assessment and a second evaluation after one month of no-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
Strength changes in the weaker side compared to the contralateral, through isokinetic dynamometry.
Measured: 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 (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJul 2013
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Franca Deriu, Università degli Studi di Sassari
- Investigators
- Franca Deriu, MD; PhD, Study director, University of Sassari-Department of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010398
- Sponsor's protocol ID
- Prot.1160/L
- Acronym
- CTSM
- Status last verified
- Mar 2017
- First submitted
- 9 Dec 2013
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25922111Morrone M, Martinez G, Achene A, Scaglione M, Masala S, Manca A, Deriu F. Size and site matter: the influence of corpus callosum subregional lesions on the magnitude of cross-education of strength. Front Physiol. 2025 Feb 24;16:1554742. doi: 10.3389/fphys.2025.1554742. eCollection 2025.
PubMed 40066282Manca 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.
PubMed 32266379Manca 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.
PubMed 31100700Manca 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.
PubMed 28342828Manca 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.
PubMed 28251398Manca 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.
PubMed 27485469Manca 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.
PubMed 26637645
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological, Dynamometric, Functional and Clinical Assessment of the Cross-Training Effect in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02010398
- Acronym / sponsor ID
- CTSM / Prot.1160/L
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cross-Training healthy subjects | Active comparator | Other: Cross-Training healthy subjectsA 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. |
| Standard-Training multiple sclerosis | Active comparator | Other: Standard-training multiple sclerosisA 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. |
| Cross-Training multiple sclerosis | Experimental | Other: Cross-Training multiple sclerosisA 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. |
| Healthy Control | No intervention | –A cohort of healthy subjects (N=15) will undergo baseline assessment and a second evaluation after one month of no-intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18-65 years
- Expanded Disability Status Scale (EDSS) ≤6 (Pyramidal functional system ≥3)
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-Training healthy subjectsThe phase of intervention will consist of a 6-week cross-training of the stronger limb employing an isokinetic contraction regimen at maximal intensity. | Other | Cross-Training healthy subjects |
| Cross-Training multiple sclerosisThe phase of intervention will consist of a 6-week cross-training of the less-impaired limb employing an isokinetic contraction regimen at maximal intensity. | Other | Cross-Training multiple sclerosis |
| Standard-training multiple sclerosisThe 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. | Other | Standard-Training multiple sclerosis |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Results publication: PubMed 25922111Manca 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.
- Derived from this study: PubMed 40066282Morrone M, Martinez G, Achene A, Scaglione M, Masala S, Manca A, Deriu F. Size and site matter: the influence of corpus callosum subregional lesions on the magnitude of cross-education of strength. Front Physiol. 2025 Feb 24;16:1554742. doi: 10.3389/fphys.2025.1554742. eCollection 2025.
- Derived from this study: PubMed 32266379Manca 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.
- Derived from this study: PubMed 31100700Manca 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.
- Derived from this study: PubMed 28342828Manca 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.
- Derived from this study: PubMed 28251398Manca 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.
- Derived from this study: PubMed 27485469Manca 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.
- Derived from this study: PubMed 26637645Manca 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.
- A comprehensive assessment of the cross-training effect in ankle dorsiflexors of healthy subjects: A randomized controlled study.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franca Deriu, MD; PhD study director
University of Sassari-Department of Biomedical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-Training healthy subjects, Cross-Training multiple sclerosis and Standard-training multiple sclerosis in people with Multiple Sclerosis and Weakness, run by Università degli Studi di Sassari at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010398, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.